510(k) Report

Devices descending from K991079

93 later devices reach Accusign Bzo, Biosign Bzo, Status Bzo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012300Acon Bzo One Step Benzodiazepines Test Strip; Acon Bzo One Step Benzodiazepines Test…ACON Laboratories, Inc.200192—
+2K121065Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Dipcard Drugs of…Polymed Therapeutics, Inc.20130—
+2K052197First Sign Drug of Abuse Urine Screening TestW.H.P.M., Inc.20060—
+2K041743Acon Tri-Fect Drug Screen Test DeviceACON Laboratories, Inc.20040—
+2K041685Acon Multi-Clin Drug Screen Test DeviceACON Laboratories, Inc.20041—
+2K023946Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug…ACON Laboratories, Inc.200386—
+3K122752Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug…Branan Medical Corp.20130—
+3K061005Accustep Doa Single and Multi-Strip Screen PanelsApplied Dna Technologies, Inc.20061—
+3K031759Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug…ACON Laboratories, Inc.2003831
+4K082977Bionexia Opticup Multi-Strip Doa Dipstick Test Integrated CupMk Bio, Inc.20090—
+4K061718Innovacon Spectrum II Test CardInnovacon, Inc.2006806
+4K050878ON Call Multi-Drug Home Test CupACON Laboratories, Inc.20050—
+4K041221Accu-Stat Home Drug Test Cup for Maijuanna (THC), Cocaine (Coc), Amphetamine (Amp)…Accu-Stat Diagnostics, Inc.20040—
+5K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen…Chemtron Biotech, Inc.20162—
+5K152590ACCU NEWS Drug Screening Test Card/Urine CupCoretests, Inc.20160—
+5K143599Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000Chemtron Biotech, Inc.20150—
+5K142396Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette TestsChemtron Biotech, Inc.201410—
+5K130213Quickprofile Single Drug of Abuse Device and Quick Profile Multi-Drugs of Abuse Screen…Lumiquick Diagnostics, Inc.20130—
+5K122809Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech201355—
+5K111322Chemtrue Single/Multi-Panel Drug Screen Cassette/DipcardChemtron Biotech, Inc.20116—
+6K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…Chemtron Biotech, Inc.20231—
+6K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.20230—
+6K201494ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardAdvin Biotech, Inc.20200—
+6K182123ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardAdvin Biotech, Inc.201911—
+6K182701Wondfo T-Cup Multi-Drug Urine Test CupGuangzhou Wondfo Biotech Co., Ltd.2018131
+6K182654SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip CardSafecare Biotech (Hangzhou) Co., Ltd.20182—
+6K181768AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd.201812—
+6K181968SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-CardSafecare Biotech (Hangzhou) Co., Ltd.20180—
+6K181790CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd.20180—
+6K180255CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd.20180—
+6K171695First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of…W.H.P.M., Inc.20180—
+6K170049AssureTech Panel Dip Test, AssureTech Quick Cup TestAssure Tech. (Hangzhou) Co, Ltd.20170—
+6K161044AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)…Assure Tech. (Hangzhou) Co, Ltd.20160—
+6K161214Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC…Guangzhou Wondfo Biotech Co., Ltd.20160—
+6K152908Ucp Compact Drug TestsUcp Biosciences, Inc.20160—
+6K153465AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)…Assure Tech. (Hangzhou) Co, Ltd.20160—
+6K152551First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse…W.H.P.M., Inc.20150—
+6K152025AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)…Assure Tech. Co., Ltd.20150—
+6K152269Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip…Healgen Scientific,, LLC20151—
+6K142800Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd.201413—
+6K142580Chemtrue Multi-Panel DOA DIP Card TestsChemtron Biotech, Inc.20144—
+6K140748One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test DipcardCo-Innovation Biotech Co., Ltd.201416—
+6K123080Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette TestsChemtron Biotech, Inc.20125—
+7K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.20260—
+7K252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxGuangzhou Wondfo Biotech Co., Ltd.20250—
+7K243996AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test…Assure Tech., LLC20252—
+7K242077PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test CupAicheck Biotech, Inc.20240—
+7K232604LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit…Hangzhou Laihe Biotech Co., Ltd.20240—
+7K232597LYHER® Urine Multi-Drug Test Kit (Cup), LYHER® Urine Multi-Drug Test Kit (Cassette)…Hangzhou Laihe Biotech Co., Ltd.20240—
+7K222667Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup RxVivachek Biotech (Hangzhou) Co., Ltd.20221—
+7K220685HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup RxQingdao Hightop Biotech Co., Ltd.20220—
+7K201630AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup TestsAssure Tech. (Hangzhou) Co, Ltd.20218—
+7K210327First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign…W.H.P.M., Inc.20210—
+7K202567Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel RxGuangzhou Wondfo Biotech Co., Ltd.20204—
+7K201120SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip CardSafecare Biotech (Hangzhou) Co., Ltd.20201—
+7K191841Accurate Multi Panel Drug Urine Test CupHealstone Biotech, Inc.20191—
+7K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC20170—
+7K160793First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of…W.H.P.M., Inc.20160—
+7K153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd.201611—
+7K152643EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test…Nantong Egens Biotech Co., Ltd.20150—
+7K151348Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test…Healgen Scientific,, LLC20152—
+7K151557EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine -…Nantong Egens Biotech Co., Ltd.20150—
+7K150602CR3 Keyless Split Sample Cup Morphine - MethamphetamineGuangzhou Wondfo Biotech Co., Ltd.20151—
+8K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxGuangzhou Wondfo Biotech Co., Ltd.20260—
+8K252554Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test CupVivachek Biotech (Hangzhou) Co., Ltd.20250—
+8K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupAssure Tech., LLC20251—
+8K242498Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTCAicheck Biotech, Inc.20240—
+8K232228Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine…Shanghai Accurature Diagnostics Co., Ltd.20240—
+8K232659Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test CupGuangzhou Decheng Biotechnology Co., Ltd.20236—
+8K233062BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel RxVivachek Biotech (Hangzhou) Co., Ltd.20231—
+8K230238BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup RxShenzhen Bioeasy Biotechnology Co., Ltd.20230—
+8K222955Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.20230—
+8K221871Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of…Healstone Biotech, Inc.20220—
+8K202453SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-CardSafecare Biotech (Hangzhou) Co., Ltd.20210—
+8K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas Medical20190—
+8K182530BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd.20185—
+8K180349AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd.20181—
+8K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC20160—
+8K151478Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo Biotech Co., Ltd.20150—
+9K261984AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupAssure Tech., LLC20260—
+9K261280BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelVivachek Biotech (Hangzhou) Co., Ltd.20260—
+9K250067Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup ProGuangzhou Decheng Biotechnology Co., Ltd.20250—
+9K240698Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardGuangzhou Decheng Biotechnology Co., Ltd.20240—
+9K240686Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…Healgen Scientific,, LLC20243—
+9K193480BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd.20200—
+9K192515BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY…Shenzhen Bioeasy Biotechnology Co., Ltd.20191—
+9K192301BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test StripShenzhen Bioeasy Biotechnology Co., Ltd.20191—
+9K190412CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd.20190—
+10K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…Healgen Scientific,, LLC20250—
+10K250803Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupAnhui Deepblue Medical Technological Co., Ltd.20250—
+10K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine…Healgen Scientific,, LLC20240—
+10K232732Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid…Co-Innovation Biotech Co., Ltd.20240—
+10K231978BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx…Vivachek Biotech (Hangzhou) Co., Ltd.20230—