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
1657–1680 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Sep 25, 1991
ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT
K913414 · LAT
Roche Diagnostic Systems, Inc.
Toxicology · 62d
Cleared Sep 25, 1991
ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III
K913677 · LAS
Analytical Control Systems, Inc.
Toxicology · 37d
Cleared Sep 25, 1991
URINE AMPHETAMINE DIRECT RIA KIT (I-125)
K913866 · DJP
Immunalysis Corporation
Toxicology · 29d
Cleared Sep 23, 1991
INNOFLUOR(TM) DIGITOXIN REAGENT SET
K913187 · LFM
Intl. Bioclinical, Inc.
Toxicology · 67d
Cleared Sep 19, 1991
EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS
K913123 · KLS
Syva Co.
Toxicology · 66d
Cleared Sep 19, 1991
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
K913863 · DJG
Immunalysis Corporation
Toxicology · 23d
Cleared Sep 19, 1991
URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)
K913867 · KLN
Immunalysis Corporation
Toxicology · 23d
Cleared Sep 18, 1991
URINE THC DIRECT RIA KIT (I-125)
K913865 · LAT
Immunalysis Corporation
Toxicology · 22d
Cleared Sep 16, 1991
EMIT(R) 2000 GENTAMICIN ASSAY/CALIBRATORS
K913410 · DMB
Syva Co.
Toxicology · 47d
Cleared Sep 10, 1991
ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE
K913722 · KLN
Roche Diagnostic Systems, Inc.
Toxicology · 25d
Cleared Sep 10, 1991
IL TEST(TM) DAT CALIBRATOR A( -)
K913739 · DKB
Instrumentation Laboratory CO
Toxicology · 21d
Cleared Sep 06, 1991
DIGITOXIN (FPIA) KIT
K913240 · LFM
Tudor Laboratories, Inc.
Toxicology · 46d
Cleared Aug 30, 1991
INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET
K913186 · DLJ
Intl. Bioclinical, Inc.
Toxicology · 43d
Cleared Aug 26, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE
K912755 · DJP
Roche Diagnostic Systems, Inc.
Toxicology · 66d
Cleared Aug 26, 1991
EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS
K913190 · DLZ
Syva Co.
Toxicology · 39d
Cleared Aug 26, 1991
ABUSCREEN(R) ONLINE(TM) CALIBRATORS
K913335 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 34d
Cleared Aug 26, 1991
ABUSCREEN(R) ONLINE(TM) CONTROLS
K913336 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 34d
Cleared Aug 26, 1991
EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS
K913429 · DIP
Syva Co.
Toxicology · 25d
Cleared Aug 16, 1991
TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS
K912365 · JXN
Abbott Laboratories
Toxicology · 79d
Cleared Aug 16, 1991
STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY
K913236 · DHA
Baxter Healthcare Corp
Toxicology · 25d
Cleared Aug 16, 1991
OPUS(R) PROLACTIN TEST SYSTEM
K913280 · CFT
Pb Diagnostic Systems, Inc.
Toxicology · 23d
Cleared Aug 12, 1991
CHOLINESTERASE TEST KIT
K912148 · DIH
Crestat Diagnostics, Inc.
Toxicology · 89d
Cleared Aug 12, 1991
ABUSCREEN ONLINE FOR THC (50 AND 100)
K912574 · LAT
Roche Diagnostic Systems, Inc.
Toxicology · 61d
Cleared Aug 12, 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ
K913107 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 31d