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
625–648 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Nov 06, 2002
AMEDICA DRUG SCREEN COCAINE TEST
K022954 · DIO
Amedica Biotech, Inc.
Toxicology · 62d
Cleared Nov 06, 2002
AMEDICA DRUG SCREEN THC TEST
K022955 · LDJ
Amedica Biotech, Inc.
Toxicology · 62d
Cleared Nov 06, 2002
AMEDICA DRUG SCREEN OPIATES TEST
K023047 · DJG
Amedica Biotech, Inc.
Toxicology · 55d
Cleared Nov 05, 2002
COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE
K020920 · DJG
Cozart Bioscience , Ltd.
Toxicology · 229d
Cleared Oct 24, 2002
QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM
K023058 · KXT
Seradyn
Toxicology · 41d
Cleared Oct 18, 2002
NICALERT
K021688 · MRS
Nymox Pharmaceutical Corporation
Toxicology · 149d
Cleared Sep 23, 2002
FERTILITE OV
K020808 · NGE
Pheromone Sciences Corp.
Toxicology · 195d
Cleared Aug 30, 2002
INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST
K022564 · DKZ
Alfa Scientific Designs, Inc.
Toxicology · 28d
Cleared Aug 21, 2002
IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
K022603 · CEW
Diagnostic Products Corp.
Toxicology · 15d
Cleared Aug 15, 2002
CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071
K021887 · LDJ
Lin-Zhi International, Inc.
Toxicology · 69d
Cleared Jul 30, 2002
VERDICT-II
K022141 · DJC
Medtox Diagnostics, Inc.
Toxicology · 28d
Cleared Jul 30, 2002
QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61
K022355 · DIO
Branan Medical Corp.
Toxicology · 11d
Cleared Jul 23, 2002
'RAPIDTEC' 5A MULTIPLE DIP TEST
K021114 · DKZ
American Bio Medica Corp.
Toxicology · 109d
Cleared Jul 16, 2002
ONLINE DAT II METHADONE II
K021505 · DJR
Roche Diagnostics Corp.
Toxicology · 68d
Cleared Jul 16, 2002
COBAS INTEGRA ONLINE DAT II METHADONE II
K021512 · DJR
Roche Diagnostics Corp.
Toxicology · 68d
Cleared Jul 12, 2002
ROCHE ONLINE GENTAMICIN
K020704 · LCD
Roche Diagnostics Corp.
Toxicology · 130d
Cleared Jul 11, 2002
ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020792 · LDP
Bayer Diagnostics Corp.
Toxicology · 122d
Cleared Jul 11, 2002
SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020794 · DKJ
Bayer Diagnostics Corp.
Toxicology · 122d
Cleared Jun 18, 2002
CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K021449 · DLJ
Lin-Zhi International, Inc.
Toxicology · 43d
Cleared Jun 13, 2002
PRECISET DAT PLUS
K021393 · DKB
Quantimetrix Corp.
Toxicology · 42d
Cleared Jun 11, 2002
FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY)
K020869 · DKZ
Worldwide Medical Corp.
Toxicology · 85d
Cleared Jun 10, 2002
LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA,...
K014066 · LDJ
Princeton BioMeditech Corp.
Toxicology · 182d
Cleared Jun 10, 2002
LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK...
K014067 · DIO
Princeton BioMeditech Corp.
Toxicology · 182d
Cleared Jun 10, 2002
LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC
K014069 · DIO
Princeton BioMeditech Corp.
Toxicology · 182d