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
1489–1512 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jan 13, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
K935591 · LDJ
Microgenics Corp.
Toxicology · 55d
Cleared Jan 11, 1994
CEDIA(R) DAU OPIATE ASSAY
K935346 · DJG
Microgenics Corp.
Toxicology · 67d
Cleared Jan 06, 1994
EMIT(R) IIC OPIATE ASSAY
K935117 · DJG
Syva Co.
Toxicology · 71d
Cleared Jan 03, 1994
EMIT IIC NEGATIVE CONTROL, CONTROL I AND II
K935230 · DIF
Syva Co.
Toxicology · 63d
Cleared Jan 03, 1994
ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK
K935550 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 47d
Cleared Dec 29, 1993
ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS
K932548 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 217d
Cleared Dec 29, 1993
BIOTRACK VALPROIC ACID TEST CARTRIDGE
K934061 · LEG
Biotrack, Inc.
Toxicology · 132d
Cleared Dec 29, 1993
BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS
K934062 · DIF
Biotrack, Inc.
Toxicology · 132d
Cleared Dec 29, 1993
CEDIA DIGOXIN PLUS ASSAY
K934168 · KXT
Microgenics Corp.
Toxicology · 124d
Cleared Dec 29, 1993
PHENCYCLIDINE EIA ASSAY
K935320 · LCM
Diagnostic Reagents, Inc.
Toxicology · 76d
Cleared Dec 22, 1993
OPUS DIGITOXIN
K935229 · DPG
Pb Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Dec 07, 1993
MICRO EIA FOR AMPHETAMINE METABOLITES
K932304 · DKZ
Microdiagnostics, Inc.
Toxicology · 209d
Cleared Dec 07, 1993
STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA
K934376 · DIS
Solarcare, Inc.
Toxicology · 89d
Cleared Nov 26, 1993
PARAMAX(R) PHENYTOIN REAGENT
K932686 · DIP
Baxter Diagnostics, Inc.
Toxicology · 176d
Cleared Nov 22, 1993
AMPHETAMINE TEST SYSTEM
K934693 · DKZ
U.S. Drug Testing, Inc.
Toxicology · 53d
Cleared Nov 22, 1993
OPUS NAPA
K934705 · LAN
Pb Diagnostic Systems, Inc.
Toxicology · 53d
Cleared Nov 22, 1993
STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPINES EIA
K934869 · JXM
Solarcare Technologies Corp,Inc.
Toxicology · 41d
Cleared Nov 15, 1993
ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN)
K932732 · KXT
Dupont Medical Products
Toxicology · 161d
Cleared Nov 09, 1993
DUPONT ACA URINE METHADONE CALIBRATOR
K934144 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 76d
Cleared Nov 09, 1993
DUPONT ACA URINE METHADONE CONTROL
K934145 · LAS
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 76d
Cleared Nov 09, 1993
DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK
K934147 · DJR
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 76d
Cleared Oct 29, 1993
MICROLINE SCREEN FOR BARBITURATES
K933480 · DIS
Drug Screening Systems, Inc.
Toxicology · 106d
Cleared Oct 27, 1993
BECKMAN CX AMMONIA/ALCOHOL CONTROL
K934467 · DKC
Beckman-Diagnostic Systems Group
Toxicology · 47d
Cleared Oct 01, 1993
EMIT(R) THC 50/100 NG ASSAY
K932716 · LDJ
Syva Co.
Toxicology · 119d