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
1417–1440 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Sep 09, 1994
THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED
K942552 · DIF
Medi-Tech, Inc.
Toxicology · 101d
Cleared Sep 09, 1994
QMS THEOPHYLLINE CS
K942991 · LGS
Seradyn, Inc.
Toxicology · 81d
Cleared Sep 09, 1994
PROPOXPHENE EIA TEST
K943414 · JXN
Diagnostic Reagents, Inc.
Toxicology · 56d
Cleared Sep 09, 1994
EZ-SCREEN:PCP
K943711 · LCM
Editek, Inc.
Toxicology · 39d
Cleared Sep 07, 1994
CEDIA DAU OPIATE ASSAY
K941195 · DJG
Microgenics Corp.
Toxicology · 177d
Cleared Sep 06, 1994
ATOMSPEC GF BLOOD LEAD WORKSTATION
K936060 · DOF
Thermo Jarrell Ash Corp.Div.Thermo Inst.
Toxicology · 260d
Cleared Aug 30, 1994
CEDIA DAU BARBITURATE ASSAY
K942436 · DIS
Microgenics Corp.
Toxicology · 124d
Cleared Aug 24, 1994
MICROGENICS THC CONTROL SETS
K943048 · LAS
Microgenics Corp.
Toxicology · 58d
Cleared Aug 18, 1994
AXSYM TOBRAMYCIN
K941614 · LFW
Abbott Laboratories
Toxicology · 136d
Cleared Aug 16, 1994
AXSYM VALPROIC ACID
K941615 · LEG
Abbott Laboratories
Toxicology · 134d
Cleared Aug 09, 1994
ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)
K935055 · DOE
Roche Diagnostic Systems, Inc.
Toxicology · 293d
Cleared Aug 08, 1994
BIOSCAN REAGENT STRIPS
K943008 · JJB
Genesis Labs, Inc.
Toxicology · 45d
Cleared Aug 01, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
K942337 · LDJ
Microgenics Corp.
Toxicology · 77d
Cleared Aug 01, 1994
CEDIA DAU BENZODIAZEPINE ASSAY
K942795 · JXM
Microgenics Corp.
Toxicology · 54d
Cleared Jul 28, 1994
CEDIA(R) DAU BARBITURATE ASSAY, MODIFICATION
K942404 · DIS
Microgenics Corp.
Toxicology · 129d
Cleared Jul 20, 1994
OPUS PROCAINAMIDE TEST SYSTEM
K934762 · LAR
Pb Diagnostic Systems, Inc.
Toxicology · 289d
Cleared Jul 20, 1994
DOA LIQUID DRUGS OF ABUSE CONTROLS LEVLS 2,3,& 4,G2,G3,& G4
K940433 · DIF
Medical Analysis Systems, Inc.
Toxicology · 170d
Cleared Jul 20, 1994
CEDIA DAU AMPHETAMINES ASSAY
K941372 · DKZ
Microgenics Corp.
Toxicology · 120d
Cleared Jul 14, 1994
AIA-PACK TT3 ASSAY
K936229 · CDP
Tosoh Medics, Inc.
Toxicology · 197d
Cleared Jul 13, 1994
CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS
K936166 · DIF
Medical Analysis Systems, Inc.
Toxicology · 203d
Cleared Jul 13, 1994
SR1 DHEA-S ENZYME IMMUNOASSAY
K942051 · JKC
Serono Diagnostics, Inc.
Toxicology · 76d
Cleared Jul 06, 1994
URINE CALIBRATOR
K940935 · DKB
Diagnostic Reagents, Inc.
Toxicology · 131d
Cleared Jul 06, 1994
COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS
K941440 · LBZ
Roche Diagnostic Systems, Inc.
Toxicology · 104d
Cleared Jun 21, 1994
AXSYM TOTAL T3
K934517 · CDP
Abbott Laboratories
Toxicology · 274d