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
1009–1032 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Nov 18, 1998
DBEST OPIATES TEST KIT
K983190 · DJG
Ameritek, Inc.
Toxicology · 68d
Cleared Nov 18, 1998
DBEST COCAINE TEST KIT
K983191 · DIO
Ameritek, Inc.
Toxicology · 68d
Cleared Nov 18, 1998
MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY
K983268 · LFH
Diagnostic Reagents, Inc.
Toxicology · 62d
Cleared Nov 18, 1998
ONTRAK TESTCUP-ER
K983388 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 54d
Cleared Nov 16, 1998
NAPA EIA ASSAY
K983812 · LAN
Diagnostic Reagents, Inc.
Toxicology · 19d
Cleared Nov 12, 1998
AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U
K982831 · JXM
OraSure Technologies, Inc.
Toxicology · 93d
Cleared Nov 12, 1998
DIGOXIN IMMUNOASSAY
K983323 · KXT
Diagnostic Reagents, Inc.
Toxicology · 51d
Cleared Nov 06, 1998
VANCOMYCIN EIA ASSAY
K983280 · LEH
Diagnostic Reagents, Inc.
Toxicology · 49d
Cleared Nov 05, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT
K983151 · KXT
Beckman Coulter, Inc.
Toxicology · 57d
Cleared Nov 05, 1998
DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS
K983159 · DKB
Diagnostic Reagents, Inc.
Toxicology · 57d
Cleared Nov 04, 1998
AUTO-LYTE PCP EIA, MODEL #1254U
K982801 · LCM
OraSure Technologies, Inc.
Toxicology · 86d
Cleared Nov 04, 1998
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I
K983209 · DKB
Beckman Coulter, Inc.
Toxicology · 51d
Cleared Oct 28, 1998
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1
K983709 · DIF
Beckman Coulter, Inc.
Toxicology · 7d
Cleared Oct 16, 1998
QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150
K982621 · MVO
Phamatech
Toxicology · 80d
Cleared Oct 14, 1998
SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR
K982935 · KXT
Beckman Coulter, Inc.
Toxicology · 54d
Cleared Oct 13, 1998
DRUG CALIBRATOR II
K982871 · DKB
Dade Behring, Inc.
Toxicology · 60d
Cleared Sep 28, 1998
ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN...
K983147 · DKE
Princeton BioMeditech Corp.
Toxicology · 20d
Cleared Sep 21, 1998
QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN...
K982152 · DIS
Phamatech
Toxicology · 95d
Cleared Sep 14, 1998
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3
K983127 · DIF
Medical Analysis Systems, Inc.
Toxicology · 6d
Cleared Aug 27, 1998
'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME
K981705 · DKZ
American Bio Medica Corp.
Toxicology · 105d
Cleared Aug 25, 1998
ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
K981801 · LFH
Princeton BioMeditech Corp.
Toxicology · 96d
Cleared Aug 25, 1998
STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)
K982061 · DIO
OraSure Technologies, Inc.
Toxicology · 82d
Cleared Aug 25, 1998
DIMENSION(R) VALPROIC (VALP) ACID METHOD
K982880 · LEG
Dade Behring, Inc.
Toxicology · 11d
Cleared Aug 18, 1998
ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE...
K982551 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 27d