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

1465–1488 of 3,029

Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology

Cleared Apr 06, 1994

CEDIA DAU THC CALIBRATORS

Microgenics Corp.

Toxicology · 120d

Cleared Apr 05, 1994

CEDIA(R) DAU PCP ASSAY

Microgenics Corp.

Toxicology · 133d

Cleared Mar 28, 1994

IL TEST(TM) TRIGLYCERIDE

Instrumentation Laboratory CO

Toxicology · 389d

Cleared Mar 22, 1994

DRUGS OF ABUSE CONTROLS

Medical Diagnostic Technologies, Inc.

Toxicology · 139d

Cleared Mar 22, 1994

QUALITY CONTROL MATERIAL (ASSAYED)

Columbia Diagnostics, Inc.

Toxicology · 109d

Cleared Mar 22, 1994

CEDIA DAU BARBITURATE ASSAY

Microgenics Corp.

Toxicology · 95d

Cleared Mar 21, 1994

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)

Eastman Kodak Company

Toxicology · 202d

Cleared Mar 14, 1994

CEDIA DAU NEGATIVE CALIBRATOR

Microgenics Corp.

Toxicology · 97d

Cleared Mar 14, 1994

CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB

Microgenics Corp.

Toxicology · 87d

Cleared Mar 11, 1994

PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS

Baxter Diagnostics, Inc.

Toxicology · 113d

Cleared Mar 11, 1994

CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS

Microgenics Corp.

Toxicology · 91d

Cleared Mar 11, 1994

COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS

Roche Diagnostic Systems, Inc.

Toxicology · 78d

Cleared Mar 11, 1994

COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS

Roche Diagnostic Systems, Inc.

Toxicology · 78d

Cleared Feb 25, 1994

QMS PHENOBARBITAL

Toxicology · 169d

Cleared Feb 17, 1994

TRI-TECH INC. CUSTOM SEXUAL ASSAULT KIT

Toxicology · 639d

Cleared Feb 10, 1994

Medical Implements, Inc.

Toxicology · 213d

Cleared Jan 27, 1994

ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE

Roche Diagnostic Systems, Inc.

Toxicology · 343d

Cleared Jan 27, 1994

URINE CALIBRATORS AND CONTROLS MODIFICATION

Diagnostic Reagents, Inc.

Toxicology · 99d

Cleared Jan 26, 1994

METHADONE ENZYME IMMUNOASSAY

Diagnostic Reagents, Inc.

Toxicology · 119d

Cleared Jan 25, 1994

ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT

Roche Diagnostic Systems, Inc.

Toxicology · 96d

Cleared Jan 25, 1994

CEDIA DAU 5-DRUG CALIBRATORS

Microgenics Corp.

Toxicology · 49d

Cleared Jan 25, 1994

CEDIA DAU 4-DRUG CUTOFF CALIBRATOR

Microgenics Corp.

Toxicology · 49d

Cleared Jan 13, 1994

ALKO FLUIDS PACKS FOR NOVA ANALYZERS

Alko Diagnostic Corp.

Toxicology · 364d

Cleared Jan 13, 1994

AMPHETAMINES EIA ASSAY MODIFICATION

Diagnostic Reagents, Inc.

Toxicology · 114d