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
409–432 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared May 17, 2007
SERADYN QMS TOPIRAMATE
K070645 · NWM
Seradyn, Inc.
Toxicology · 70d
Cleared May 07, 2007
MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE...
K063545 · DJG
Alfa Scientific Designs, Inc.
Toxicology · 164d
Cleared Apr 09, 2007
RMI LCD ALCOHOL DETECTOR
K062545 · DJZ
Resource Management International, LLC
Toxicology · 222d
Cleared Feb 16, 2007
ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS
K063520 · OAV
Roche Diagnostics
Toxicology · 87d
Cleared Dec 28, 2006
VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1,...
K063164 · LDJ
Ortho-Clinical Diagnostics, Inc.
Toxicology · 71d
Cleared Dec 20, 2006
AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150
K063015 · DJG
Ameditech, Inc.
Toxicology · 79d
Cleared Dec 18, 2006
QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA
K062929 · DIO
Quest Diagnostics, Inc.
Toxicology · 81d
Cleared Dec 18, 2006
BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS
K062971 · DJZ
Akers Biosciences, Inc.
Toxicology · 80d
Cleared Dec 11, 2006
AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS...
K063379 · DKZ
Amedica Biotech, Inc.
Toxicology · 33d
Cleared Dec 05, 2006
IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
K063045 · LEH
Diagnostic Products Corp.
Toxicology · 62d
Cleared Dec 05, 2006
ESA LEADCARE II LEAD CONTROL
K063398 · DIF
Bionostics, Inc.
Toxicology · 26d
Cleared Nov 13, 2006
INNOVACON SPECTRUM II TEST CARD
K061718 · DKZ
Innovacon, Inc.
Toxicology · 147d
Cleared Oct 30, 2006
QUANTIMETRIX NICOSURE COTININE URINE CONTROL
K062942 · LAS
Quantimetrix Corp.
Toxicology · 32d
Cleared Oct 04, 2006
ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS
K061005 · DKZ
Applied Dna Technologies, Inc.
Toxicology · 176d
Cleared Sep 14, 2006
DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)
K062162 · DKB
Dade Behring, Inc.
Toxicology · 48d
Cleared Sep 14, 2006
DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520
K062182 · DLJ
Dade Behring, Inc.
Toxicology · 45d
Cleared Sep 06, 2006
DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)
K062199 · DLJ
Dade Behring, Inc.
Toxicology · 36d
Cleared Aug 23, 2006
ONLINE TDM PROCAINAMIDE
K060773 · LAR
Roche Diagnostics Corp.
Toxicology · 154d
Cleared Aug 21, 2006
UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS
K061457 · LFG
Ucp Biosciences, Inc.
Toxicology · 88d
Cleared Aug 21, 2006
DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS...
K062191 · DIF
Dade Behring, Inc.
Toxicology · 21d
Cleared Aug 16, 2006
TDM N-ACETYLPROCAINAMIDE
K060738 · LAN
Roche Diagnostics Corp.
Toxicology · 149d
Cleared Aug 08, 2006
ONLINE VALPROIC ACID
K060690 · LEG
Roche Diagnostics Corp.
Toxicology · 146d
Cleared Aug 07, 2006
ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000
K060355 · DJC
Acro Biotech, LLC
Toxicology · 175d
Cleared Aug 07, 2006
RAPIDONE-BUPRENORPHINE TEST
K060760 · DJG
American Bio Medica Corp.
Toxicology · 139d