510(k) Report

Devices descending from K122809

55 later devices reach Advin Multi-Drug Screen Test Cassette, Dip Card and Cup through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.20230—
+1K201494ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardAdvin Biotech, Inc.20200—
+1K182123ATTEST Drug Screen Cup, ATTEST Drug Screen Dip CardAdvin Biotech, Inc.201911—
+1K182701Wondfo T-Cup Multi-Drug Urine Test CupGuangzhou Wondfo Biotech Co., Ltd.2018131
+1K181768AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd.201812—
+1K171695First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of…W.H.P.M., Inc.20180—
+1K161214Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC…Guangzhou Wondfo Biotech Co., Ltd.20160—
+1K152908Ucp Compact Drug TestsUcp Biosciences, Inc.20160—
+1K152551First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse…W.H.P.M., Inc.20150—
+1K152269Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip…Healgen Scientific,, LLC20151—
+1K142800Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd.201413—
+1K140748One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test DipcardCo-Innovation Biotech Co., Ltd.201416—
+2K252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxGuangzhou Wondfo Biotech Co., Ltd.20250—
+2K243996AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test…Assure Tech., LLC20252—
+2K242077PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test CupAicheck Biotech, Inc.20240—
+2K232604LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit…Hangzhou Laihe Biotech Co., Ltd.20240—
+2K232597LYHER® Urine Multi-Drug Test Kit (Cup), LYHER® Urine Multi-Drug Test Kit (Cassette)…Hangzhou Laihe Biotech Co., Ltd.20240—
+2K222667Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup RxVivachek Biotech (Hangzhou) Co., Ltd.20221—
+2K220685HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup RxQingdao Hightop Biotech Co., Ltd.20220—
+2K201630AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup TestsAssure Tech. (Hangzhou) Co, Ltd.20218—
+2K210327First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign…W.H.P.M., Inc.20210—
+2K202567Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel RxGuangzhou Wondfo Biotech Co., Ltd.20204—
+2K191841Accurate Multi Panel Drug Urine Test CupHealstone Biotech, Inc.20191—
+2K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC20170—
+2K160793First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of…W.H.P.M., Inc.20160—
+2K153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd.201611—
+2K151348Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test…Healgen Scientific,, LLC20152—
+3K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxGuangzhou Wondfo Biotech Co., Ltd.20260—
+3K252554Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test CupVivachek Biotech (Hangzhou) Co., Ltd.20250—
+3K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupAssure Tech., LLC20251—
+3K242498Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTCAicheck Biotech, Inc.20240—
+3K232228Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine…Shanghai Accurature Diagnostics Co., Ltd.20240—
+3K232659Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test CupGuangzhou Decheng Biotechnology Co., Ltd.20236—
+3K233062BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel RxVivachek Biotech (Hangzhou) Co., Ltd.20231—
+3K230238BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup RxShenzhen Bioeasy Biotechnology Co., Ltd.20230—
+3K222955Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.20230—
+3K221871Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of…Healstone Biotech, Inc.20220—
+3K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas Medical20190—
+3K182530BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd.20185—
+3K180349AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd.20181—
+3K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC20160—
+4K261984AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupAssure Tech., LLC20260—
+4K261280BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelVivachek Biotech (Hangzhou) Co., Ltd.20260—
+4K250067Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup ProGuangzhou Decheng Biotechnology Co., Ltd.20250—
+4K240698Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardGuangzhou Decheng Biotechnology Co., Ltd.20240—
+4K240686Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…Healgen Scientific,, LLC20243—
+4K193480BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd.20200—
+4K192515BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY…Shenzhen Bioeasy Biotechnology Co., Ltd.20191—
+4K192301BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test StripShenzhen Bioeasy Biotechnology Co., Ltd.20191—
+4K190412CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd.20190—
+5K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…Healgen Scientific,, LLC20250—
+5K250803Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupAnhui Deepblue Medical Technological Co., Ltd.20250—
+5K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine…Healgen Scientific,, LLC20240—
+5K232732Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid…Co-Innovation Biotech Co., Ltd.20240—
+5K231978BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx…Vivachek Biotech (Hangzhou) Co., Ltd.20230—