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
361–384 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Feb 11, 2009
RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052
K080436 · DIO
Quantrx Biomedical Corporation
Toxicology · 358d
Cleared Feb 06, 2009
EQ-PRC LC WARFARIN GENOTYPING KIT
K073071 · ODW
Trimgen Corporation
Toxicology · 464d
Cleared Jan 14, 2009
DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS
K081378 · DJR
Thermo Fisher Scientific
Toxicology · 243d
Cleared Jan 08, 2009
RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054
K080431 · LCM
Quantrx Biomedical Corporation
Toxicology · 324d
Cleared Dec 31, 2008
RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050
K080455 · LAF
Quantrx Biomedical Corporation
Toxicology · 315d
Cleared Dec 22, 2008
BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN...
K081008 · DJG
Lin-Zhi International, Inc.
Toxicology · 256d
Cleared Dec 22, 2008
ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND...
K082953 · KXT
Biokit, S.A.
Toxicology · 80d
Cleared Dec 19, 2008
CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS
K081083 · OAV
Thermo Fisher Scientific
Toxicology · 247d
Cleared Dec 19, 2008
IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)
K081855 · DJZ
Canada, Inc.
Toxicology · 172d
Cleared Dec 19, 2008
KEY RING ALCOHOL BREATHALYZER
K082086 · DJZ
The Ashley Collection, Inc.
Toxicology · 149d
Cleared Dec 19, 2008
AMEDICA DRUG SCREEN TEST CUP
K082898 · NGL
Amedica Biotech, Inc.
Toxicology · 80d
Cleared Dec 05, 2008
DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B
K082001 · JII
Diazyme Laboratories
Toxicology · 144d
Cleared Nov 25, 2008
BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP,...
K080467 · LDJ
Applied Dna Technologies, Inc.
Toxicology · 278d
Cleared Nov 21, 2008
FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD
K082508 · DJG
Branan Medical Corporation
Toxicology · 84d
Cleared Oct 30, 2008
DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR,...
K081857 · NRP
Siemens Healthcare Diagnostics, Inc.
Toxicology · 121d
Cleared Oct 09, 2008
UNISCAN -DOA SYSTEM
K080347 · DJC
Taiwan Unison Biotech, Inc.
Toxicology · 244d
Cleared Sep 26, 2008
ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS,...
K081231 · DLZ
Abbott Laboratories
Toxicology · 148d
Cleared Sep 11, 2008
ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR
K071455 · MKW
Siemens Medical Solutions Diagnostics
Toxicology · 475d
Cleared Sep 11, 2008
ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH...
K080696 · DIP
Abbott Laboratories
Toxicology · 183d
Cleared Sep 11, 2008
ARCHITECT CYCLOSPORINE
K080751 · MKW
Fujirebio Diagnostics,Inc.
Toxicology · 177d
Cleared Aug 22, 2008
DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440
K082030 · DLJ
Siemens Healthcare Diagnostics, Inc.
Toxicology · 36d
Cleared Aug 05, 2008
DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
K081992 · MKW
Siemens Healthcare Diagnostics, Inc.
Toxicology · 22d
Cleared Jul 17, 2008
ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT
K073720 · ODW
Osmetech Molecular Diagnostics
Toxicology · 199d
Cleared Jun 25, 2008
QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA
K080381 · LAF
Quest Diagnostics, Inc.
Toxicology · 133d