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
1273–1296 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Nov 03, 1995
ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI
K954571 · DIO
Princeton BioMeditech Corp.
Toxicology · 32d
Cleared Oct 30, 1995
COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID
K953224 · LEG
Roche Diagnostic Systems, Inc.
Toxicology · 139d
Cleared Oct 26, 1995
ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4,...
K945549 · DIO
Princeton BioMeditech Corp.
Toxicology · 346d
Cleared Oct 26, 1995
ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC
K952361 · DIO
Princeton BioMeditech Corp.
Toxicology · 171d
Cleared Oct 26, 1995
AXSYM PHENCYCLIDINE II
K953534 · LCM
Abbott Laboratories
Toxicology · 91d
Cleared Oct 11, 1995
TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL
K954322 · DIF
Medical Analysis Systems, Inc.
Toxicology · 26d
Cleared Oct 06, 1995
AXSYM AMPHETAMINE/METHAMPHETAMINE II
K953115 · DKZ
Abbott Laboratories
Toxicology · 95d
Cleared Oct 05, 1995
VISUALINE II BENZODIAZEPINES
K953105 · JXM
Sun Biomedical Laboratories, Inc.
Toxicology · 94d
Cleared Sep 27, 1995
AXSYM REA ETHANOL
K953765 · DML
Abbott Laboratories
Toxicology · 47d
Cleared Sep 25, 1995
MECTEST
K945207 · DIO
Meco Industries
Toxicology · 335d
Cleared Sep 25, 1995
AXSYM DIGOXIN II
K953718 · KXT
Abbott Laboratories
Toxicology · 47d
Cleared Sep 25, 1995
AXSYM PHENYTOIN II
K953840 · LGR
Abbott Laboratories
Toxicology · 40d
Cleared Sep 20, 1995
ABUSCREEN ONLINE CONTROLS
K953739 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 44d
Cleared Sep 20, 1995
ABUSCREEN ONLINE DRUG FREE URINE
K953845 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 35d
Cleared Sep 12, 1995
ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN
K953528 · LEH
Roche Diagnostic Systems, Inc.
Toxicology · 47d
Cleared Sep 06, 1995
ACETAMINOPHEN ASSAY
K952949 · LDP
Diagnostic Chemicals , Ltd.
Toxicology · 72d
Cleared Aug 24, 1995
BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY
K952839 · DML
Boehringer Mannheim Corp.
Toxicology · 64d
Cleared Aug 24, 1995
AXSYM THEOPHYLLINE II
K953016 · LGS
Abbott Laboratories
Toxicology · 56d
Cleared Aug 24, 1995
AXSYM ACETAMINOPHEN
K953094 · LDP
Abbott Laboratories
Toxicology · 52d
Cleared Aug 17, 1995
ONE STEP URINE DRUG OF ABUSE COCAINE TEST
K951892 · DIO
Tcpi, Inc.
Toxicology · 115d
Cleared Aug 17, 1995
ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE)
K952096 · DJG
Tcpi, Inc.
Toxicology · 105d
Cleared Aug 11, 1995
THEOPHYLLINE ENZYME IMMUNOASSAY
K952596 · KLS
Diagnostic Reagents, Inc.
Toxicology · 66d
Cleared Aug 08, 1995
AXSYM SALICYLATE
K951290 · DKJ
Abbott Laboratories
Toxicology · 140d
Cleared Aug 08, 1995
BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT
K952568 · LCR
Beckman Instruments, Inc.
Toxicology · 64d