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
1609–1632 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Mar 18, 1992
DRUG OF ABUSE URINE CONTROL
K920477 · DIF
Diagnostic Reagents, Inc.
Toxicology · 50d
Cleared Mar 18, 1992
THC URINE CALIBRATORS
K920749 · DLJ
Diagnostic Reagents, Inc.
Toxicology · 28d
Cleared Mar 18, 1992
ABUSCREEN ONLINE FOR PHENCYCLIDINE
K920935 · LCM
Roche Diagnostic Systems, Inc.
Toxicology · 19d
Cleared Mar 18, 1992
PHENCYCLIDINE EIA ASSAY, MODIFICATION
K920957 · LCM
Diagnostic Reagents, Inc.
Toxicology · 49d
Cleared Mar 13, 1992
SYVA EMIT II METHADONE ASSAY
K920751 · DJR
Syva Co.
Toxicology · 23d
Cleared Mar 11, 1992
IL TEST DAT CAL/CONTROL SET D/E
K920419 · DLG
Instrumentation Laboratory CO
Toxicology · 40d
Cleared Mar 04, 1992
URINE A CALIBRATOR
K920208 · DKB
Diagnostic Reagents, Inc.
Toxicology · 48d
Cleared Mar 02, 1992
CEDIA DIGOXIN ASSAY (MODIFICATION)
K920214 · KXT
Microgenics Corp.
Toxicology · 46d
Cleared Feb 27, 1992
CANNABINOID EIA TEST
K920311 · LDJ
Diagnostic Reagents, Inc.
Toxicology · 35d
Cleared Feb 27, 1992
IL TEST CANNABINOID, 35282
K920418 · LDJ
Instrumentation Laboratory CO
Toxicology · 27d
Cleared Feb 27, 1992
EMIT II MONOCLONAL AMPHETAMINE/ METHAMPH. ASSAY
K920507 · DKZ
Syva Co.
Toxicology · 22d
Cleared Feb 24, 1992
URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL
K912888 · MIG
Dynagen, Inc.
Toxicology · 238d
Cleared Feb 19, 1992
WATERS 717 AUTOSAMPLER
K920136 · LDM
Millipore Corp.
Toxicology · 37d
Cleared Feb 18, 1992
EMIT D.A.U BENZODIAZEPINE ASSAY
K915501 · JXM
Syva Co.
Toxicology · 71d
Cleared Jan 28, 1992
ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL
K915516 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Jan 27, 1992
DIGITOXIN FPIA REAGENT SET
K915465 · LFM
Sigma Diagnostics, Inc.
Toxicology · 56d
Cleared Jan 24, 1992
MODEL IRC PASSPORT NEBULIZER
K914251 · LAW
Invacare Corp.
Toxicology · 123d
Cleared Jan 22, 1992
MICROLINE SCREEN FOR CANNABINOID
K914915 · LDJ
Drug Screening Systems, Inc.
Toxicology · 79d
Cleared Jan 22, 1992
OPIATE EIA ASSAY
K915180 · DJG
Diagnostic Reagents, Inc.
Toxicology · 68d
Cleared Jan 17, 1992
SRI DIGOXIN ENZYME IMMUNOASSAY
K915602 · KXT
Serono-Baker Diagnostics, Inc.
Toxicology · 35d
Cleared Jan 15, 1992
CEDIA(R) CARBAMAZEPINE ASSAY
K914857 · KLT
Microgenics Corp.
Toxicology · 78d
Cleared Jan 15, 1992
DIGITOXIN FPIA CALIBRATOR SET
K915464 · DLJ
Sigma Diagnostics, Inc.
Toxicology · 44d
Cleared Dec 27, 1991
SIGMA PROCEDURE NO. 333-UV
K914777 · DML
Sigma Diagnostics, Inc.
Toxicology · 65d
Cleared Dec 18, 1991
DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE
K914507 · LAT
Diagnostic Products Corp.
Toxicology · 70d