510(k) Report

Devices descending from K994395

17 later devices reach Instant-View Amphetamine Urine Cassette Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063545Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test (Cassette…Alfa Scientific Designs, Inc.200716—
+2K152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test…Alfa Scientific Designs, Inc.201613—
+2K131645Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette)Alfa Scientific Designs, Inc.20130—
+2K100051Instant-View Milti-Drug of Abuse Urine Test (Panel, Cup), Instant-Verdict Multi-Drug of…Alfa Scientific Designs, Inc.20100—
+3K173303INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW…Alfa Scientific Designs, Inc.201812—
+4K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug…Hangzhou AllTest Biotech Co., Ltd.20199—
+4K180878BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test…Shanghai Venture Bio-Tech Co., Ltd.20180—
+4K180879BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug…Shanghai Venture Bio-Tech Co., Ltd.20180—
+5K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest…Hangzhou AllTest Biotech Co., Ltd.20238—
+6K244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.20254—
+6K241428AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.20242—
+7K261409BioTeke® Multi-Drug Urine Test CupBioteke Corporation (Wuxi) Co., Ltd.20260—
+7K260355Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine CupWEBEST Biotech,, LLC20260—
+7K252867VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupAdvin Biotech, Inc.20250—
+7K250727AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupHangzhou AllTest Biotech Co., Ltd.20251—
+7K242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.20240—
+8K252118CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy CupHangzhou Clongene Biotech Co., Ltd.20250—