510(k) Report

Devices descending from K971218

20 later devices reach Quikstrip One Step Amphetamine Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131069Quickscreen Amphetine 500 TestPhamatech, Inc.20140—
+1K994395Instant-View Amphetamine Urine Cassette TestAlfa Scientific Designs, Inc.200017—
+1K994399Instant-View Amphetamine Urine Dip Strip TestAlfa Scientific Designs, Inc.20000—
+2K063545Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test (Cassette…Alfa Scientific Designs, Inc.200716—
+3K152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test…Alfa Scientific Designs, Inc.201613—
+3K131645Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette)Alfa Scientific Designs, Inc.20130—
+3K100051Instant-View Milti-Drug of Abuse Urine Test (Panel, Cup), Instant-Verdict Multi-Drug of…Alfa Scientific Designs, Inc.20100—
+4K173303INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW…Alfa Scientific Designs, Inc.201812—
+5K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug…Hangzhou AllTest Biotech Co., Ltd.20199—
+5K180878BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test…Shanghai Venture Bio-Tech Co., Ltd.20180—
+5K180879BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug…Shanghai Venture Bio-Tech Co., Ltd.20180—
+6K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest…Hangzhou AllTest Biotech Co., Ltd.20238—
+7K244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.20254—
+7K241428AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.20242—
+8K261409BioTeke® Multi-Drug Urine Test CupBioteke Corporation (Wuxi) Co., Ltd.20260—
+8K260355Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine CupWEBEST Biotech,, LLC20260—
+8K252867VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupAdvin Biotech, Inc.20250—
+8K250727AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupHangzhou AllTest Biotech Co., Ltd.20251—
+8K242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.20240—
+9K252118CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy CupHangzhou Clongene Biotech Co., Ltd.20250—