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

457–480 of 3,029

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

Cleared May 11, 2006

ENZYME IMMUNOASSAY, VANCOMYCIN

Roche Diagnostics Corp.

Toxicology · 65d

Cleared May 05, 2006

ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST

Acro Biotech, LLC

Toxicology · 190d

Cleared May 03, 2006

ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000

Acro Biotech, LLC

Toxicology · 79d

Cleared Apr 28, 2006

BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS

Akers Biosciences, Inc.

Toxicology · 38d

Cleared Apr 21, 2006

ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP...

ACON Laboratories, Inc.

Toxicology · 58d

Cleared Apr 06, 2006

OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS

Lin-Zhi International, Inc.

Toxicology · 352d

Cleared Mar 29, 2006

METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS

Lin-Zhi International, Inc.

Toxicology · 337d

Cleared Mar 21, 2006

MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL

Quantimetrix Corp.

Toxicology · 32d

Cleared Feb 23, 2006

POCKET BREATHALYZER. CONNECTABLES

Connectables, LLC

Toxicology · 169d

Cleared Feb 15, 2006

FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE

Tianjin New Bay Bioresearch Co., Ltd.

Toxicology · 126d

Cleared Feb 09, 2006

ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST

Acro Biotech, LLC

Toxicology · 105d

Cleared Feb 06, 2006

EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

Dade Behring, Inc.

Toxicology · 98d

Cleared Jan 20, 2006

BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500

Sentech Korea Corp.

Toxicology · 50d

Cleared Dec 23, 2005

QMS QUINIDINE. QMS QUINIDINE CALIBRATORS

Toxicology · 79d

Cleared Dec 08, 2005

AMEDITECH DRUGSMARTCUP

Ameditech, Inc.

Toxicology · 24d

Cleared Nov 22, 2005

QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)

Quest Diagnostics, Inc.

Toxicology · 201d

Cleared Nov 18, 2005

IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS

Immunalysis Corporation

Toxicology · 157d

Cleared Nov 17, 2005

ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS

Guangzhou Wondfo Biotech Co., Ltd.

Toxicology · 316d

Cleared Nov 01, 2005

QMS AMIKACIN REAGENTS

Toxicology · 28d

Cleared Oct 21, 2005

IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS

Immunalysis Corporation

Toxicology · 129d

Cleared Oct 13, 2005

IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS

Immunalysis Corporation

Toxicology · 115d

Cleared Oct 04, 2005

IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS

Immunalysis Corporation

Toxicology · 112d

Cleared Sep 12, 2005

DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108

Dade Behring, Inc.

Toxicology · 48d

Cleared Sep 07, 2005

FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE...

Worldwide Medical, LLC

Toxicology · 49d