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
601–624 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Apr 14, 2003
AT HOME DRUG CUP, MODEL 9150X
K030447 · MVO
Phamatech
Toxicology · 62d
Cleared Apr 11, 2003
ONLINE DAT II CANNABINOIDS II
K030213 · LDJ
Roche Diagnostics Corp.
Toxicology · 80d
Cleared Apr 07, 2003
COZART EIA OPIATES ORAL FLUID KIT
K024339 · DIG
Cozart Bioscience , Ltd.
Toxicology · 101d
Cleared Apr 03, 2003
PRECISET DAT AMPHETAMINE
K030826 · DIJ
Quantimetrix Corp.
Toxicology · 20d
Cleared Mar 31, 2003
CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5
K030616 · LAS
Microgenics Corp.
Toxicology · 33d
Cleared Feb 27, 2003
STARTOX DRUG OF ABUSE SCREENING TEST (4)
K022388 · DJC
Starplex Scientific, Inc.
Toxicology · 219d
Cleared Feb 11, 2003
WAKO NEFA LINEARITY SET
K030065 · JJX
Wako Chemicals USA, Inc.
Toxicology · 35d
Cleared Feb 10, 2003
DRI PRIMIDONE CALIBRATORS
K023780 · DLJ
Microgenics Corp.
Toxicology · 90d
Cleared Feb 05, 2003
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP...
K023946 · DIS
ACON Laboratories, Inc.
Toxicology · 70d
Cleared Jan 31, 2003
ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST
K023712 · DKZ
Advantage Diagnostics Corp.
Toxicology · 88d
Cleared Jan 21, 2003
PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000...
K023795 · JXN
Lin-Zhi International, Inc.
Toxicology · 69d
Cleared Dec 16, 2002
AMEDICA DRUG SCREEN METHAPHETAMINE TEST
K023101 · LAF
Amedica Biotech, Inc.
Toxicology · 89d
Cleared Dec 16, 2002
AMEDICA DRUG SCREEN AMPHETAMINE TEST
K023104 · DKZ
Amedica Biotech, Inc.
Toxicology · 89d
Cleared Dec 16, 2002
AMEDICA DRUG SCREEN PHENCYCLIDINE TEST
K023109 · LCM
Amedica Biotech, Inc.
Toxicology · 89d
Cleared Dec 16, 2002
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K023316 · DLJ
Lin-Zhi International, Inc.
Toxicology · 74d
Cleared Dec 16, 2002
QUICKTOX MULTIPLE DRUG DIPCARD
K023489 · DIO
Branan Medical Corp.
Toxicology · 60d
Cleared Dec 12, 2002
METHADONE ENZYME IMMUNOASSAY
K023317 · DJR
Lin-Zhi International, Inc.
Toxicology · 70d
Cleared Dec 10, 2002
VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
K023876 · JIX
Ortho-Clinical Diagnostics, Inc.
Toxicology · 19d
Cleared Dec 09, 2002
INSTANT-VIEW TCA URINE TEST
K022693 · MLK
Alfa Scientific Designs, Inc.
Toxicology · 118d
Cleared Dec 06, 2002
ONLINE DAT II COCAINE II
K023281 · DIO
Roche Diagnostics Corp.
Toxicology · 66d
Cleared Nov 25, 2002
COBAS INTEGRA ONLINE DAT II COCAINE II
K023296 · DIO
Roche Diagnostics Corp.
Toxicology · 54d
Cleared Nov 22, 2002
RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020
K023252 · DJR
Icn Biomedicals, Inc.
Toxicology · 53d
Cleared Nov 13, 2002
INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST
K022501 · DJC
Alfa Scientific Designs, Inc.
Toxicology · 107d
Cleared Nov 07, 2002
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
K023048 · JXM
Beckman Coulter, Inc.
Toxicology · 55d