510(k) Report

Devices descending from K010841

95 later devices reach Acon Coc One Step Cocaine Test Strip, Acon Coc One Step Cocaine Test Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121065Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Dipcard Drugs of…Polymed Therapeutics, Inc.20130—
+1K080436Rapidsense Drugs of Abuse Cocaine (Coc) 300 Device, Model 900-0052Quantrx Biomedical Corporation20090—
+1K050594Nano-Check Dat 5 Multi Drug Screening Test for Cannabinoids, Opiates, Cocaine…Nano-Ditech Co.20050—
+1K041743Acon Tri-Fect Drug Screen Test DeviceACON Laboratories, Inc.20040—
+1K041685Acon Multi-Clin Drug Screen Test DeviceACON Laboratories, Inc.20041—
+1K020313Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug…Acon Laboratories Co.200288—
+2K122752Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug…Branan Medical Corp.20130—
+2K061005Accustep Doa Single and Multi-Strip Screen PanelsApplied Dna Technologies, Inc.20061—
+2K050936ON Call Home Drug Test for Marijuana and on Call Home Drug Test for Marijuana and CocaineACON Laboratories, Inc.20050—
+2K050050ON Call Multi-Drug Home TestACON Laboratories, Inc.20050—
+2K031759Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug…ACON Laboratories, Inc.2003831
+3K082977Bionexia Opticup Multi-Strip Doa Dipstick Test Integrated CupMk Bio, Inc.20090—
+3K061718Innovacon Spectrum II Test CardInnovacon, Inc.2006806
+3K050878ON Call Multi-Drug Home Test CupACON Laboratories, Inc.20050—
+3K041221Accu-Stat Home Drug Test Cup for Maijuanna (THC), Cocaine (Coc), Amphetamine (Amp)…Accu-Stat Diagnostics, Inc.20040—
+4K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen…Chemtron Biotech, Inc.20162—
+4K152590ACCU NEWS Drug Screening Test Card/Urine CupCoretests, Inc.20160—
+4K143599Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000Chemtron Biotech, Inc.20150—
+4K142396Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette TestsChemtron Biotech, Inc.201410—
+4K130213Quickprofile Single Drug of Abuse Device and Quick Profile Multi-Drugs of Abuse Screen…Lumiquick Diagnostics, Inc.20130—
+4K122809Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech201355—
+4K111322Chemtrue Single/Multi-Panel Drug Screen Cassette/DipcardChemtron Biotech, Inc.20116—
+5K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…Chemtron Biotech, Inc.20231—
+5K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.20230—
+5K201494ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardAdvin Biotech, Inc.20200—
+5K182123ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardAdvin Biotech, Inc.201911—
+5K182701Wondfo T-Cup Multi-Drug Urine Test CupGuangzhou Wondfo Biotech Co., Ltd.2018131
+5K182654SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip CardSafecare Biotech (Hangzhou) Co., Ltd.20182—
+5K181768AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd.201812—
+5K181968SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-CardSafecare Biotech (Hangzhou) Co., Ltd.20180—
+5K181790CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd.20180—
+5K180255CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd.20180—
+5K171695First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of…W.H.P.M., Inc.20180—
+5K170049AssureTech Panel Dip Test, AssureTech Quick Cup TestAssure Tech. (Hangzhou) Co, Ltd.20170—
+5K161044AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)…Assure Tech. (Hangzhou) Co, Ltd.20160—
+5K161214Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC…Guangzhou Wondfo Biotech Co., Ltd.20160—
+5K152908Ucp Compact Drug TestsUcp Biosciences, Inc.20160—
+5K153465AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)…Assure Tech. (Hangzhou) Co, Ltd.20160—
+5K152551First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse…W.H.P.M., Inc.20150—
+5K152025AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)…Assure Tech. Co., Ltd.20150—
+5K152269Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip…Healgen Scientific,, LLC20151—
+5K142800Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd.201413—
+5K142580Chemtrue Multi-Panel DOA DIP Card TestsChemtron Biotech, Inc.20144—
+5K140748One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test DipcardCo-Innovation Biotech Co., Ltd.201416—
+5K123080Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette TestsChemtron Biotech, Inc.20125—
+6K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.20260—
+6K252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxGuangzhou Wondfo Biotech Co., Ltd.20250—
+6K243996AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test…Assure Tech., LLC20252—
+6K242077PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test CupAicheck Biotech, Inc.20240—
+6K232604LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit…Hangzhou Laihe Biotech Co., Ltd.20240—
+6K232597LYHER® Urine Multi-Drug Test Kit (Cup), LYHER® Urine Multi-Drug Test Kit (Cassette)…Hangzhou Laihe Biotech Co., Ltd.20240—
+6K222667Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup RxVivachek Biotech (Hangzhou) Co., Ltd.20221—
+6K220685HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup RxQingdao Hightop Biotech Co., Ltd.20220—
+6K201630AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup TestsAssure Tech. (Hangzhou) Co, Ltd.20218—
+6K210327First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign…W.H.P.M., Inc.20210—
+6K202567Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel RxGuangzhou Wondfo Biotech Co., Ltd.20204—
+6K201120SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip CardSafecare Biotech (Hangzhou) Co., Ltd.20201—
+6K191841Accurate Multi Panel Drug Urine Test CupHealstone Biotech, Inc.20191—
+6K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC20170—
+6K160793First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of…W.H.P.M., Inc.20160—
+6K153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd.201611—
+6K152643EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test…Nantong Egens Biotech Co., Ltd.20150—
+6K151348Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test…Healgen Scientific,, LLC20152—
+6K151557EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine -…Nantong Egens Biotech Co., Ltd.20150—
+6K150602CR3 Keyless Split Sample Cup Morphine - MethamphetamineGuangzhou Wondfo Biotech Co., Ltd.20151—
+7K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxGuangzhou Wondfo Biotech Co., Ltd.20260—
+7K252554Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test CupVivachek Biotech (Hangzhou) Co., Ltd.20250—
+7K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupAssure Tech., LLC20251—
+7K242498Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTCAicheck Biotech, Inc.20240—
+7K232228Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine…Shanghai Accurature Diagnostics Co., Ltd.20240—
+7K232659Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test CupGuangzhou Decheng Biotechnology Co., Ltd.20236—
+7K233062BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel RxVivachek Biotech (Hangzhou) Co., Ltd.20231—
+7K230238BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup RxShenzhen Bioeasy Biotechnology Co., Ltd.20230—
+7K222955Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.20230—
+7K221871Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of…Healstone Biotech, Inc.20220—
+7K202453SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-CardSafecare Biotech (Hangzhou) Co., Ltd.20210—
+7K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas Medical20190—
+7K182530BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd.20185—
+7K180349AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd.20181—
+7K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC20160—
+7K151478Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo Biotech Co., Ltd.20150—
+8K261984AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupAssure Tech., LLC20260—
+8K261280BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelVivachek Biotech (Hangzhou) Co., Ltd.20260—
+8K250067Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup ProGuangzhou Decheng Biotechnology Co., Ltd.20250—
+8K240698Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardGuangzhou Decheng Biotechnology Co., Ltd.20240—
+8K240686Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…Healgen Scientific,, LLC20243—
+8K193480BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd.20200—
+8K192515BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY…Shenzhen Bioeasy Biotechnology Co., Ltd.20191—
+8K192301BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test StripShenzhen Bioeasy Biotechnology Co., Ltd.20191—
+8K190412CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd.20190—
+9K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…Healgen Scientific,, LLC20250—
+9K250803Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupAnhui Deepblue Medical Technological Co., Ltd.20250—
+9K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine…Healgen Scientific,, LLC20240—
+9K232732Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid…Co-Innovation Biotech Co., Ltd.20240—
+9K231978BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx…Vivachek Biotech (Hangzhou) Co., Ltd.20230—