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Guangzhou Wondfo Biotech Co., Ltd.

43 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx (K260065)Guangzhou Wondfo Biotech Co., Ltd.2026-04-28
SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx (K252550)Guangzhou Wondfo Biotech Co., Ltd.2025-11-18
WELLlife COVID-19 Antigen Test Rx (K251289)Guangzhou Wondfo Biotech Co., Ltd.2025-10-22
Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (K241317)Guangzhou Wondfo Biotech Co., Ltd.2024-09-30
SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel (K241741)Guangzhou Wondfo Biotech Co., Ltd.2024-07-16
Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx (K202567)Guangzhou Wondfo Biotech Co., Ltd.2020-09-25
Wondfo T-Cup Multi-Drug Urine Test Cup (K182701)Guangzhou Wondfo Biotech Co., Ltd.2018-12-03
Preview Digital Pregnancy Test (K173229)Guangzhou Wondfo Biotech Co., Ltd.2018-03-12
Wondfo One Step Fecal Occult Blood (FOB) Test (K162333)Guangzhou Wondfo Biotech Co., Ltd.2017-05-14
Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) (K161214)Guangzhou Wondfo Biotech Co., Ltd.2016-06-27
Wondfo Propoxyphene Urine Test (K152495)Guangzhou Wondfo Biotech Co., Ltd.2015-11-23
Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream (K150022)Guangzhou Wondfo Biotech Co., Ltd.2015-08-07
Wondfo CR3 Keyless Split Sample Cup (K151478)Guangzhou Wondfo Biotech Co., Ltd.2015-07-01
CR3 Keyless Split Sample Cup Morphine - Methamphetamine (K150602)Guangzhou Wondfo Biotech Co., Ltd.2015-04-07
CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids (K150179)Guangzhou Wondfo Biotech Co., Ltd.2015-02-25
CR3 Keyless Split Sample Cup Secobarbital- Methadone (K143535)Guangzhou Wondfo Biotech Co., Ltd.2015-01-13
CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine (K142609)Guangzhou Wondfo Biotech Co., Ltd.2014-12-18
CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE (K142044)Guangzhou Wondfo Biotech Co., Ltd.2014-08-25
CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE (K141532)Guangzhou Wondfo Biotech Co., Ltd.2014-07-14
CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO) (K140089)Guangzhou Wondfo Biotech Co., Ltd.2014-04-08
WONDFO MULTI-DRUG URINE TEST CUP, PANEL (K133968)Guangzhou Wondfo Biotech Co., Ltd.2014-02-25
WONDFO RAPID STREP A TEST (K133343)Guangzhou Wondfo Biotech Co., Ltd.2014-01-31
WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) (K132630)Guangzhou Wondfo Biotech Co., Ltd.2013-09-27
WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) (K131754)Guangzhou Wondfo Biotech Co., Ltd.2013-07-31
WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) (K131232)Guangzhou Wondfo Biotech Co., Ltd.2013-05-31
WONDOFO MULTI-DRUG URINE TEST CUP / PANEL (K130665)Guangzhou Wondfo Biotech Co., Ltd.2013-04-09
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP (K130055)Guangzhou Wondfo Biotech Co., Ltd.2013-02-14
WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500) (K122961)Guangzhou Wondfo Biotech Co., Ltd.2012-12-21
WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU; (K122904)Guangzhou Wondfo Biotech Co., Ltd.2012-11-15
WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST (K121987)Guangzhou Wondfo Biotech Co., Ltd.2012-08-01
WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST (K121557)Guangzhou Wondfo Biotech Co., Ltd.2012-07-25
WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL (K121166)Guangzhou Wondfo Biotech Co., Ltd.2012-05-08
WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST (K113624)Guangzhou Wondfo Biotech Co., Ltd.2012-03-12
WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P (K112071)Guangzhou Wondfo Biotech Co., Ltd.2011-09-23
WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST (K112236)Guangzhou Wondfo Biotech Co., Ltd.2011-09-19
WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST (K112395)Guangzhou Wondfo Biotech Co., Ltd.2011-09-09
WONDFO METHADONE URINE TEST,OPIATE TEST (K112310)Guangzhou Wondfo Biotech Co., Ltd.2011-09-08
WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST (K111560)Guangzhou Wondfo Biotech Co., Ltd.2011-07-15
CANNABINOIDS URINE TEST (K110182)Guangzhou Wondfo Biotech Co., Ltd.2011-05-20
WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES (K093175)Guangzhou Wondfo Biotech Co., Ltd.2010-08-25
ONE STEP HCG URINE/SERUM TEST (K072500)Guangzhou Wondfo Biotech Co., Ltd.2009-04-21
ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS (K050024)Guangzhou Wondfo Biotech Co., Ltd.2005-11-17
ONE STEP HCG URINE PREGNANCY TEST (K043443)Guangzhou Wondfo Biotech Co., Ltd.2005-04-08

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Every clearance here is in the API, with alerts when new ones post.