Medical Device Manufacturer · US , Yardley , PA

Guangzhou Wondfo Biotech Co., Ltd. - FDA 510(k) Cleared Devices

42 submissions · 42 cleared · Since 2005
42
Total
42
Cleared
0
Denied

FDA 510(k) cleared devices by Guangzhou Wondfo Biotech Co., Ltd. Chemistry

15 devices
1-15 of 15
Cleared Mar 12, 2018
Preview Digital Pregnancy Test
K173229 · LCX
Chemistry · 159d
Cleared Aug 07, 2015
Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine...
K150022 · LCX
Chemistry · 213d
Cleared Jan 13, 2015
CR3 Keyless Split Sample Cup Secobarbital- Methadone
K143535 · DIS
Chemistry · 29d
Cleared Aug 25, 2014
CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE
K142044 · LCM
Chemistry · 28d
Cleared Feb 25, 2014
WONDFO MULTI-DRUG URINE TEST CUP, PANEL
K133968 · DKZ
Chemistry · 61d
Cleared Dec 21, 2012
WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST...
K122961 · DKZ
Chemistry · 87d
Cleared Aug 01, 2012
WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO...
K121987 · DKZ
Chemistry · 26d
Cleared Jul 25, 2012
WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST
K121557 · LDJ
Chemistry · 61d
Cleared Mar 12, 2012
WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST
K113624 · DJG
Chemistry · 95d
Cleared Sep 23, 2011
WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE...
K112071 · DIO
Chemistry · 65d
Cleared Sep 19, 2011
WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST
K112236 · LAF
Chemistry · 46d
Cleared Jul 15, 2011
WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO...
K111560 · DKZ
Chemistry · 42d
Cleared May 20, 2011
CANNABINOIDS URINE TEST
K110182 · LDJ
Chemistry · 119d
Cleared Apr 21, 2009
ONE STEP HCG URINE/SERUM TEST
K072500 · DHA
Chemistry · 594d
Cleared Apr 08, 2005
ONE STEP HCG URINE PREGNANCY TEST
K043443 · LCX
Chemistry · 115d
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