Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

43 results for "Guangzhou Wondfo Biotech Co., Ltd."
25–43 of 43
Search insights Median review: 61d Cleared: 100% Top manufacturer: Guangzhou Wondfo Biotech Co., Ltd. Lead specialty: Toxicology
Cleared May 31, 2013
WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)
K131232 · DJR
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 30d
Cleared Apr 09, 2013
WONDOFO MULTI-DRUG URINE TEST CUP / PANEL
K130665 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 28d
Cleared Feb 14, 2013
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP
K130055 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 36d
Cleared Dec 21, 2012
WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST...
K122961 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 87d
Cleared Nov 15, 2012
WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU
K122904 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 55d
Cleared Aug 01, 2012
WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO...
K121987 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 26d
Cleared Jul 25, 2012
WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST
K121557 · LDJ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 61d
Cleared May 08, 2012
WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL
K121166 · DIO
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 21d
Cleared Mar 12, 2012
WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST
K113624 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 95d
Cleared Sep 23, 2011
WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE...
K112071 · DIO
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 65d
Cleared Sep 19, 2011
WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST
K112236 · LAF
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 46d
Cleared Sep 09, 2011
WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST
K112395 · LFG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 21d
Cleared Sep 08, 2011
WONDFO METHADONE URINE TEST,OPIATE TEST
K112310 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 29d
Cleared Jul 15, 2011
WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO...
K111560 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 42d
Cleared May 20, 2011
CANNABINOIDS URINE TEST
K110182 · LDJ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 119d
Cleared Aug 25, 2010
WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE...
K093175 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 321d
Cleared Apr 21, 2009
ONE STEP HCG URINE/SERUM TEST
K072500 · DHA
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 594d
Cleared Nov 17, 2005
ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS
K050024 · DIS
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 316d
Cleared Apr 08, 2005
ONE STEP HCG URINE PREGNANCY TEST
K043443 · LCX
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 115d