Company · US
Guangzhou Wondfo Biotech Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.
43510(k) clearances (2 in 12 months)
3recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 8 |
| DKZ | Enzyme Immunoassay, Amphetamine | 6 |
| DIS | Enzyme Immunoassay, Barbiturate | 5 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 4 |
| NFT | Test, Amphetamine, Over The Counter | 4 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 3 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 2 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | 2 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 |
| DJC | Thin Layer Chromatography, Methamphetamine | 1 |
| DJR | Enzyme Immunoassay, Methadone | 1 |
| DNK | Thin Layer Chromatography, Morphine | 1 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 |
| JXN | Enzyme Immunoassay, Propoxyphene | 1 |
| KHE | Reagent, Occult Blood | 1 |
| LAF | Gas Chromatography, Methamphetamine | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 |
| NGL | Test, Opiates, Over The Counter | 1 |
| QVF | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | 1 |
| QYT | Over-The-Counter Covid-19 Antigen Test | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 28, 2026 | K260065 | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx Guangzhou Wondfo Biotech Co., Ltd., CN | NFT |
| Nov 18, 2025 | K252550 | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx Guangzhou Wondfo Biotech Co., Ltd., CN | NFT |
| Oct 22, 2025 | K251289 | WELLlife COVID-19 Antigen Test Rx Guangzhou Wondfo Biotech Co., Ltd., CN | QVF |
| Sep 30, 2024 | K241317 | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) Guangzhou Wondfo Biotech Co., Ltd., CN | QYT |
| Jul 16, 2024 | K241741 | SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Ur Guangzhou Wondfo Biotech Co., Ltd., CN | NGL |
| Sep 25, 2020 | K202567 | Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx Guangzhou Wondfo Biotech Co., Ltd., CN | NFT |
| Dec 3, 2018 | K182701 | Wondfo T-Cup Multi-Drug Urine Test Cup Guangzhou Wondfo Biotech Co., Ltd., CN | NFT |
| Mar 12, 2018 | K173229 | Preview Digital Pregnancy Test Guangzhou Wondfo Biotech Co., Ltd., CN | LCX |
| May 14, 2017 | K162333 | Wondfo One Step Fecal Occult Blood (FOB) Test Guangzhou Wondfo Biotech Co., Ltd., CN | KHE |
| Jun 27, 2016 | K161214 | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphet Guangzhou Wondfo Biotech Co., Ltd., CN | DIO |
| Nov 23, 2015 | K152495 | Wondfo Propoxyphene Urine Test Guangzhou Wondfo Biotech Co., Ltd., CN | JXN |
| Aug 7, 2015 | K150022 | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG U Guangzhou Wondfo Biotech Co., Ltd., CN | LCX |
| Jul 1, 2015 | K151478 | Wondfo CR3 Keyless Split Sample Cup Guangzhou Wondfo Biotech Co., Ltd., CN | DJG |
| Apr 7, 2015 | K150602 | CR3 Keyless Split Sample Cup Morphine - Methamphetamine Guangzhou Wondfo Biotech Co., Ltd., CN | DNK |
| Feb 25, 2015 | K150179 | CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids Guangzhou Wondfo Biotech Co., Ltd., CN | DJG |
| Jan 13, 2015 | K143535 | CR3 Keyless Split Sample Cup Secobarbital- Methadone Guangzhou Wondfo Biotech Co., Ltd., CN | DIS |
| Dec 18, 2014 | K142609 | CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine Guangzhou Wondfo Biotech Co., Ltd., CN | LFG |
| Aug 25, 2014 | K142044 | CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE Guangzhou Wondfo Biotech Co., Ltd. | LCM |
| Jul 14, 2014 | K141532 | CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE Guangzhou Wondfo Biotech Co., Ltd. | DKZ |
| Apr 8, 2014 | K140089 | CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO) Guangzhou Wondfo Biotech Co., Ltd. | DJG |
| Feb 25, 2014 | K133968 | WONDFO MULTI-DRUG URINE TEST CUP, PANEL Guangzhou Wondfo Biotech Co., Ltd. | DKZ |
| Jan 31, 2014 | K133343 | WONDFO RAPID STREP A TEST Guangzhou Wondfo Biotech Co., Ltd. | GTY |
| Sep 27, 2013 | K132630 | WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) Guangzhou Wondfo Biotech Co., Ltd. | DJC |
| Jul 31, 2013 | K131754 | WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) Guangzhou Wondfo Biotech Co., Ltd. | DIO |
| May 31, 2013 | K131232 | WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) Guangzhou Wondfo Biotech Co., Ltd. | DJR |
| Apr 9, 2013 | K130665 | WONDOFO MULTI-DRUG URINE TEST CUP / PANEL Guangzhou Wondfo Biotech Co., Ltd. | DJG |
| Feb 14, 2013 | K130055 | ACON BUP ONE STEP BUPRENORPHINE TEST STRIP Guangzhou Wondfo Biotech Co., Ltd. | DJG |
| Dec 21, 2012 | K122961 | WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500) Guangzhou Wondfo Biotech Co., Ltd. | DKZ |
| Nov 15, 2012 | K122904 | 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. | DKZ |
| Aug 1, 2012 | K121987 | WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST Guangzhou Wondfo Biotech Co., Ltd. | DKZ |
| Jul 25, 2012 | K121557 | WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST Guangzhou Wondfo Biotech Co., Ltd. | LDJ |
| May 8, 2012 | K121166 | WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL Guangzhou Wondfo Biotech Co., Ltd. | DIO |
| Mar 12, 2012 | K113624 | WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST Guangzhou Wondfo Biotech Co., Ltd. | DJG |
| Sep 23, 2011 | K112071 | WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P Guangzhou Wondfo Biotech Co., Ltd. | DIO |
| Sep 19, 2011 | K112236 | WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST Guangzhou Wondfo Biotech Co., Ltd. | LAF |
| Sep 9, 2011 | K112395 | WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST Guangzhou Wondfo Biotech Co., Ltd. | LFG |
| Sep 8, 2011 | K112310 | WONDFO METHADONE URINE TEST,OPIATE TEST Guangzhou Wondfo Biotech Co., Ltd. | DJG |
| Jul 15, 2011 | K111560 | WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST Guangzhou Wondfo Biotech Co., Ltd. | DKZ |
| May 20, 2011 | K110182 | CANNABINOIDS URINE TEST Guangzhou Wondfo Biotech Co., Ltd. | LDJ |
| Aug 25, 2010 | K093175 | WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES Guangzhou Wondfo Biotech Co., Ltd. | DJG |
| Apr 21, 2009 | K072500 | ONE STEP HCG URINE/SERUM TEST Guangzhou Wondfo Biotech Co., Ltd. | DHA |
| Nov 17, 2005 | K050024 | ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS Guangzhou Wondfo Biotech Co., Ltd. | DIS |
| Apr 8, 2005 | K043443 | ONE STEP HCG URINE PREGNANCY TEST Guangzhou Wondfo Biotech Co., Ltd. | LCX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 18, 2018 | Guangzhou Wondfo Biotech Co., Ltd. TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S)
Product Usage:
T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral flu Open, Classified |
DIS | None listed |
| May 18, 2018 | Guangzhou Wondfo Biotech Co., Ltd. TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S)
Product Usage:
T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid Open, Classified |
DIS | None listed |
| May 18, 2018 | Guangzhou Wondfo Biotech Co., Ltd. TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S)
Product Usage:
T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is Open, Classified |
DIS | None listed |