FDA 510(k) Applications Submitted by GUANGZHOU WONDFO BIOTECH CO., LTD.

FDA 510(k) Number Submission Date Device Name Applicant
K150022 01/06/2015 Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream Guangzhou Wondfo Biotech Co., Ltd.
K150179 01/27/2015 CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids GUANGZHOU WONDFO BIOTECH CO., LTD.
K151478 06/02/2015 Wondfo CR3 Keyless Split Sample Cup GUANGZHOU WONDFO BIOTECH CO., LTD.
K152495 09/01/2015 Wondfo Propoxyphene Urine Test Guangzhou Wondfo Biotech Co., Ltd.
K142609 09/16/2014 CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine Guangzhou Wondfo Biotech Co., Ltd.
K143535 12/15/2014 CR3 Keyless Split Sample Cup Secobarbital- Methadone GUANGZHOU WONDFO BIOTECH CO., LTD.
K161214 04/29/2016 Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) GUANGZHOU WONDFO BIOTECH CO., LTD.
K162333 08/22/2016 Wondfo One Step Fecal Occult Blood (FOB) Test GUANGZHOU WONDFO BIOTECH CO., LTD.
K182701 09/27/2018 Wondfo T-Cup Multi-Drug Urine Test Cup Guangzhou Wondfo Biotech Co., Ltd.
K173229 10/04/2017 Preview Digital Pregnancy Test Guangzhou Wondfo Biotech Co., Ltd.
K072500 09/05/2007 ONE STEP HCG URINE/SERUM TEST Guangzhou Wondfo Biotech Co., Ltd.
K093175 10/08/2009 WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES Guangzhou Wondfo Biotech Co., Ltd.
K043443 12/14/2004 ONE STEP HCG URINE PREGNANCY TEST Guangzhou Wondfo Biotech Co., Ltd.
K050024 01/05/2005 ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS Guangzhou Wondfo Biotech Co., Ltd.
K130055 01/09/2013 ACON BUP ONE STEP BUPRENORPHINE TEST STRIP Guangzhou Wondfo Biotech Co., Ltd.
K140089 01/14/2014 CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO) Guangzhou Wondfo Biotech Co., Ltd.
K110182 01/21/2011 CANNABINOIDS URINE TEST Guangzhou Wondfo Biotech Co., Ltd.
K130665 03/12/2013 WONDOFO MULTI-DRUG URINE TEST CUP / PANEL Guangzhou Wondfo Biotech Co., Ltd.
K121166 04/17/2012 WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL Guangzhou Wondfo Biotech Co., Ltd.
K131232 05/01/2013 WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) Guangzhou Wondfo Biotech Co., Ltd.
K121557 05/25/2012 WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST Guangzhou Wondfo Biotech Co., Ltd.
K111560 06/03/2011 WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST Guangzhou Wondfo Biotech Co., Ltd.
K141532 06/10/2014 CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE Guangzhou Wondfo Biotech Co., Ltd.
K131754 06/14/2013 WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) Guangzhou Wondfo Biotech Co., Ltd.
K121987 07/06/2012 WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST Guangzhou Wondfo Biotech Co., Ltd.
K112071 07/20/2011 WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P Guangzhou Wondfo Biotech Co., Ltd.
K142044 07/28/2014 CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE Guangzhou Wondfo Biotech Co., Ltd.
K112236 08/04/2011 WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST Guangzhou Wondfo Biotech Co., Ltd.
K112310 08/10/2011 WONDFO METHADONE URINE TEST,OPIATE TEST Guangzhou Wondfo Biotech Co., Ltd.
K112395 08/19/2011 WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST Guangzhou Wondfo Biotech Co., Ltd.
K132630 08/22/2013 WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) Guangzhou Wondfo Biotech Co., Ltd.
K122904 09/21/2012 WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU; Guangzhou Wondfo Biotech Co., Ltd.
K122961 09/25/2012 WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500) Guangzhou Wondfo Biotech Co., Ltd.
K133343 10/30/2013 WONDFO RAPID STREP A TEST Guangzhou Wondfo Biotech Co., Ltd.
K113624 12/08/2011 WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST Guangzhou Wondfo Biotech Co., Ltd.
K133968 12/26/2013 WONDFO MULTI-DRUG URINE TEST CUP, PANEL Guangzhou Wondfo Biotech Co., Ltd.
K202567 09/04/2020 Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx Guangzhou Wondfo Biotech Co., Ltd.


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