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

Filters: Toxicology ×
3,029 results
265–288 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared CT Aug 12, 2013
SPARTAN RX CYP2C19 TEST SYSTEM
K123891 · NTI
Spartan Bioscience, Inc.
Toxicology · 237d
Cleared Aug 08, 2013
BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND...
K132090 · DLJ
Randox Laboratories, Ltd.
Toxicology · 27d
Not Cleared Aug 08, 2013
QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS
DEN130005 · PDY
Centers For Disease Control and...
Toxicology · 72d
Cleared Jul 31, 2013
WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)
K131754 · DIO
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 47d
Cleared Jul 19, 2013
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
K131811 · DKZ
Ucp Biosciences, Inc.
Toxicology · 30d
Cleared Jul 11, 2013
THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
K123343 · MLM
Microgenics Corp.
Toxicology · 253d
Cleared Jun 25, 2013
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE
K131181 · LCM
Omega Laboratories, Inc.
Toxicology · 61d
Cleared Jun 17, 2013
Advin Multi-Drug Screen Test Cassette, Dip Card and Cup
K122809 · DKZ
Advin Biotech
Toxicology · 277d
Cleared Jun 05, 2013
ABBOTT CARBAMAZEPINE ASSAY
K123518 · KLT
Microgenics Corporation
Toxicology · 203d
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 May 24, 2013
POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND...
K121065 · DKZ
Polymed Therapeutics, Inc.
Toxicology · 413d
Cleared May 15, 2013
UCP HOME DRUG SCREENING TEST
K130463 · DKZ
Ucp Biosciences, Inc.
Toxicology · 82d
Cleared May 07, 2013
FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE
K122064 · DJG
Tianjin New Bay Bioresearch Co., Ltd.
Toxicology · 298d
Cleared May 02, 2013
PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE
K130811 · DKZ
Psychemedics Corp.
Toxicology · 38d
Cleared Apr 29, 2013
PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE
K123470 · DJZ
Pas Systems International, Inc.
Toxicology · 167d
Cleared Apr 25, 2013
RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND...
K122703 · LCM
Biophor Diagnostics, Inc.
Toxicology · 233d
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 Feb 08, 2013
PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR
K123799 · DJG
Psychemedics Corp.
Toxicology · 60d
Cleared Jan 30, 2013
FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK,...
K122752 · JXN
Branan Medical Corp.
Toxicology · 145d
Cleared Jan 09, 2013
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
K123863 · DKZ
Ucp Biosciences, Inc.
Toxicology · 26d
Cleared Dec 13, 2012
ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS...
K120936 · DKB
Microgenics Corporation
Toxicology · 260d
Cleared Dec 05, 2012
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)
K122759 · LDJ
Omega Laboratories, Inc.
Toxicology · 86d
Cleared Nov 30, 2012
UCP HOME DRUG SCREENING TEST CUPS
K122419 · DKZ
Ucp Biosciences, Inc.
Toxicology · 113d