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
1921–1944 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jun 09, 1989
INNOFLUOR(TM) QUINIDINE REAGENT SET
K892208 · LBZ
Innotron of Oregon, Inc.
Toxicology · 67d
Cleared Jun 09, 1989
INNOFLUOR(TM) QUINDINE CALIBATOR SET
K892212 · DLJ
Innotron of Oregon, Inc.
Toxicology · 67d
Cleared May 23, 1989
THE CDI(R) SYSTEM 400
K890113 · DJY
Cardiovascular Devices, Inc.
Toxicology · 132d
Cleared May 22, 1989
ACA VANCOMYCIN (VANC) METHOD
K892900 · LEH
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 32d
Cleared May 16, 1989
ACA VANCOMYCIN CALIBRATOR
K892901 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 26d
Cleared May 11, 1989
DRUGS OF ABUSE URINE CALIBRATORS
K892332 · DKB
Hycor Biomedical, Inc.
Toxicology · 36d
Cleared May 03, 1989
COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT
K891167 · DLB
Diagnostic Products Corp.
Toxicology · 58d
Cleared Apr 26, 1989
ACA (R) DIGITOXIN CALIBRATOR
K891093 · DCJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 55d
Cleared Apr 26, 1989
ACA(R) DIGITOXIN (DGTX) METHOD
K891094 · LFM
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 55d
Cleared Apr 10, 1989
CRACK-IT CANNABINOID SCREEN
K874390 · LDJ
Sakers, Inc.
Toxicology · 531d
Cleared Apr 10, 1989
SHAPE-ACTIO METAL TOXICOLOGY CONTROL
K890721 · DIE
Actio, Inc.
Toxicology · 56d
Cleared Apr 04, 1989
CHROMATOGRAPHY KIT
K884176 · DPA
Gelman Sciences, Inc.
Toxicology · 182d
Cleared Mar 31, 1989
ABUSCREEN FP BENZODIAZEPHINE REAGENT
K891697 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 9d
Cleared Mar 16, 1989
ABUSCREEN FP FOR CANNABINOIDS
K890887 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 23d
Cleared Mar 15, 1989
ABUSCREEN FP FOR PHENCYCLIDINE
K890882 · LCL
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Mar 15, 1989
ABUSCREEN FP BUFFER REAGENT
K890883 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Mar 15, 1989
ABUSCREEN FP FOR MORPHINE
K890888 · DJG
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Mar 13, 1989
ABUSCREEN FP FOR COCAINE METABOLITE
K890885 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Mar 10, 1989
ABUSCREEN FP FOR AMPHETAMINE
K890886 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 17d
Cleared Mar 09, 1989
ABUSCREEN FP FOR BARBITURATES
K890884 · DIS
Roche Diagnostic Systems, Inc.
Toxicology · 16d
Cleared Mar 09, 1989
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL:
K890957 · DIF
Hycor Biomedical, Inc.
Toxicology · 10d
Cleared Feb 17, 1989
DRUG STANDARD SET
K884177 · DKB
Gelman Sciences, Inc.
Toxicology · 136d
Cleared Feb 17, 1989
DRUG CONTROL SET
K884178 · DIF
Gelman Sciences, Inc.
Toxicology · 136d
Cleared Feb 10, 1989
PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO
K884864 · JJQ
The Perkin-Elmer Corp.
Toxicology · 80d