Guangzhou Wondfo Biotech Co., Ltd. - FDA 510(k) Cleared Devices
42
Total
42
Cleared
0
Denied
FDA 510(k) cleared devices by Guangzhou Wondfo Biotech Co., Ltd. Toxicology ✕
23 devices
Cleared
Nov 18, 2025
SAFElife T-Cup Multi-Drug Urine Test Cup
Toxicology
97d
Cleared
Jul 16, 2024
SAFElife™ Fentanyl Urine Home Test (Cassette)
Toxicology
29d
Cleared
Sep 25, 2020
Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test...
Toxicology
21d
Cleared
Dec 03, 2018
Wondfo T-Cup Multi-Drug Urine Test Cup
Toxicology
67d
Cleared
Jun 27, 2016
Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine...
Toxicology
59d
Cleared
Nov 23, 2015
Wondfo Propoxyphene Urine Test
Toxicology
83d
Cleared
Jul 01, 2015
Wondfo CR3 Keyless Split Sample Cup
Toxicology
29d
Cleared
Apr 07, 2015
CR3 Keyless Split Sample Cup Morphine - Methamphetamine
Toxicology
28d
Cleared
Feb 25, 2015
CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids
Toxicology
29d
Cleared
Dec 18, 2014
CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine
Toxicology
93d
Cleared
Jul 14, 2014
CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE
Toxicology
34d
Cleared
Apr 08, 2014
CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)
Toxicology
84d
Cleared
Sep 27, 2013
WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST...
Toxicology
36d
Cleared
Jul 31, 2013
WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)
Toxicology
47d
Cleared
May 31, 2013
WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)
Toxicology
30d
Cleared
Apr 09, 2013
WONDOFO MULTI-DRUG URINE TEST CUP / PANEL
Toxicology
28d
Cleared
Feb 14, 2013
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP
Toxicology
36d
Cleared
Nov 15, 2012
WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU
Toxicology
55d
Cleared
May 08, 2012
WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL
Toxicology
21d
Cleared
Sep 09, 2011
WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST
Toxicology
21d
Cleared
Sep 08, 2011
WONDFO METHADONE URINE TEST,OPIATE TEST
Toxicology
29d
Cleared
Aug 25, 2010
WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE...
Toxicology
321d
Cleared
Nov 17, 2005
ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS
Toxicology
316d