510(k) Report

Devices descending from K142800

13 later devices reach Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160793First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of…W.H.P.M., Inc.20160—
+1K153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd.201611—
+2K232228Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine…Shanghai Accurature Diagnostics Co., Ltd.20240—
+2K222955Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.20230—
+2K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas Medical20190—
+2K182530BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd.20185—
+2K180349AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd.20181—
+3K193480BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd.20200—
+3K192515BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY…Shenzhen Bioeasy Biotechnology Co., Ltd.20191—
+3K192301BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test StripShenzhen Bioeasy Biotechnology Co., Ltd.20191—
+3K190412CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd.20190—
+4K232732Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid…Co-Innovation Biotech Co., Ltd.20240—
+4K231978BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx…Vivachek Biotech (Hangzhou) Co., Ltd.20230—