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
313–336 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Sep 08, 2011
WONDFO METHADONE URINE TEST,OPIATE TEST
K112310 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 29d
Cleared May 25, 2011
RANDOX BARITURATES ASSAY
K092268 · DIS
Randox Laboratories, Ltd.
Toxicology · 666d
Cleared May 09, 2011
RANDOX METHAMPHETAMINE ASSAY
K092266 · DKB
Randox Laboratories, Ltd.
Toxicology · 650d
Cleared May 03, 2011
ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL...
K110446 · DKZ
Roche Diagnostics
Toxicology · 76d
Cleared Apr 08, 2011
CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET
K092269 · LDJ
Randox Laboratories, Ltd.
Toxicology · 619d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
K101742 · DIO
Microgenics Corp.
Toxicology · 290d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY
K101754 · DJG
Microgenics Corp.
Toxicology · 290d
Cleared Apr 06, 2011
ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST
K102225 · DJZ
Alcopro, Inc.
Toxicology · 240d
Cleared Apr 01, 2011
ARCHITECT IGENTAMICIN REAGENTS
K102699 · LCD
Abbott Laboratories
Toxicology · 193d
Cleared Mar 24, 2011
THERMO SCIENTIFIC MAS R DOA TOTAL
K103656 · DIF
Microgenics Corporation
Toxicology · 99d
Cleared Feb 25, 2011
ROCHE FLUDI METHAMPHETAMINE
K093884 · LAF
Roche Diagnostics
Toxicology · 434d
Cleared Feb 07, 2011
SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
K103373 · DIH
Beckman Coulter, Inc.
Toxicology · 82d
Cleared Jan 20, 2011
CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS
K102203 · DKZ
Chemtron Biotech, Inc.
Toxicology · 169d
Cleared Jan 12, 2011
BREATHSCN PRO
K102338 · DJZ
Akers Biosciences, Inc.
Toxicology · 147d
Cleared Nov 23, 2010
ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL...
K101574 · OTF
ARK Diagnostics, Inc.
Toxicology · 169d
Cleared Nov 18, 2010
RANDOX METHADONE ASSAY
K092272 · DJR
Randox Laboratories, Ltd.
Toxicology · 478d
Cleared Nov 09, 2010
RANDOX METABOLITE (EDDP) ASSAY
K092258 · DJR
Randox Laboratories, Ltd.
Toxicology · 469d
Cleared Nov 01, 2010
RANDOX ETHANOL ASSAY
K092273 · DIC
Randox Laboratories, Ltd.
Toxicology · 461d
Cleared Oct 29, 2010
ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL
K101305 · ORH
ARK Diagnostics, Inc.
Toxicology · 172d
Cleared Oct 25, 2010
INFINITI CYP2C19 ASSAY
K101683 · NTI
Autogenomics, Incorporated
Toxicology · 132d
Cleared Oct 15, 2010
RANDOX BENZODIAZEPINE ASSAY
K092274 · JXM
Randox Laboratories, Ltd.
Toxicology · 444d
Cleared Aug 25, 2010
WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE...
K093175 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 321d
Cleared Aug 06, 2010
MISSION SALIVA ALCOHOL TEST STRIP
K093879 · DIC
ACON Laboratories, Inc.
Toxicology · 231d
Cleared Aug 04, 2010
CONTRALCO
K100879 · DJZ
Contralco
Toxicology · 127d