510(k) Report

Devices descending from K033047

23 later devices reach Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step Oxycodone Test… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113624Wondfo Buprenorphine Urine Test Wondfo Oxycodone Urine TestGuangzhou Wondfo Biotech Co., Ltd.20121—
+1K093175Wondfo One Step Buprenorphine Urine Test, Oxycodone Urine Test, Propoxphene Urine Test…Guangzhou Wondfo Biotech Co., Ltd.20100—
+1K063545Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test (Cassette…Alfa Scientific Designs, Inc.200716—
+1K041743Acon Tri-Fect Drug Screen Test DeviceACON Laboratories, Inc.20040—
+1K041685Acon Multi-Clin Drug Screen Test DeviceACON Laboratories, Inc.20041—
+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—
+2K130055Acon Bup One Step Buprenorphine Test StripGuangzhou Wondfo Biotech Co., Ltd.20130—
+2K122752Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug…Branan Medical Corp.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—