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
1225–1248 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared May 15, 1996
SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT
K961256 · LEG
Beckman Instruments, Inc.
Toxicology · 44d
Cleared May 15, 1996
AED CALIBRATORS
K961273 · DKB
Diagnostic Reagents, Inc.
Toxicology · 43d
Cleared May 09, 1996
AXSYM VANCOMYCIN II
K955851 · LEH
Abbott Laboratories
Toxicology · 134d
Cleared May 06, 1996
BARBITURATE SERUM TOX EIA ASSAY
K960664 · DIS
Diagnostic Reagents, Inc.
Toxicology · 80d
Cleared May 01, 1996
SERUM TOX CALIBRATOR
K961372 · DKB
Diagnostic Reagents, Inc.
Toxicology · 22d
Cleared Apr 29, 1996
SALICYLATE ASSAY
K961131 · DKJ
Diagnostic Reagents, Inc.
Toxicology · 39d
Cleared Apr 25, 1996
ACCUSIGN MET/BIOSIGN MET
K961249 · LAF
Princeton BioMeditech Corp.
Toxicology · 24d
Cleared Apr 24, 1996
AXSYM N-ACETYLPROCAINAMIDE
K955422 · LAN
Abbott Laboratories
Toxicology · 148d
Cleared Apr 04, 1996
INNOFLUOR QUINIDINE ASSAY SYSTEM
K955568 · LBZ
Oxis Intl., Inc.
Toxicology · 120d
Cleared Apr 03, 1996
SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT
K955677 · LDJ
Beckman Instruments, Inc.
Toxicology · 110d
Cleared Apr 02, 1996
ABBOTT AXSM PROCAINAMIDE ASSAY
K955444 · LAR
Abbott Laboratories
Toxicology · 126d
Cleared Apr 02, 1996
COCAINE METABOLITE EIA TEST
K960187 · DIO
Diagnostic Reagents, Inc.
Toxicology · 77d
Cleared Mar 19, 1996
SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)
K936240 · JKA
Sudormed, Inc.
Toxicology · 810d
Cleared Mar 19, 1996
STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION
K940048 · DLJ
Solarcare Technologies Corp,Inc.
Toxicology · 804d
Cleared Mar 18, 1996
PRIMIDONE EIA TEST
K960526 · DJP
Diagnostic Reagents, Inc.
Toxicology · 41d
Cleared Mar 11, 1996
ACS PHENYTOIN ASSAY
K955873 · LGR
Ciba Corning Diagnostics Corp.
Toxicology · 76d
Cleared Mar 11, 1996
BARBITURATE EIA ESSAY (MODIFICATION)
K955928 · DIS
Diagnostic Reagents, Inc.
Toxicology · 84d
Cleared Mar 06, 1996
FRONTLINE COCAINE
K954496 · DIO
Boehringer Mannheim Corp.
Toxicology · 161d
Cleared Mar 06, 1996
FRONTLINE CANNABIS
K954497 · LDJ
Boehringer Mannheim Corp.
Toxicology · 161d
Cleared Mar 06, 1996
FRONTLINE OPIATES
K954498 · DJG
Boehringer Mannheim Corp.
Toxicology · 161d
Cleared Mar 04, 1996
SYNCHRON SYSTEMS METHAQUALONE REAGENT
K955676 · KXS
Beckman Instruments, Inc.
Toxicology · 80d
Cleared Feb 23, 1996
EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS
K955448 · DLB
Behring Diagnostics, Inc.
Toxicology · 86d
Cleared Feb 16, 1996
VANCOMYCIN FPIA REAGENT SET
K955716 · LEH
Sigma Diagnostics, Inc.
Toxicology · 63d
Cleared Feb 16, 1996
TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000
K955934 · DKZ
Biosite Incorporated
Toxicology · 65d