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
529–552 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jun 03, 2004
COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT
K033743 · DKZ
Cozart Bioscience , Ltd.
Toxicology · 188d
Cleared May 28, 2004
MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT
K040758 · DIF
Microgenics Corp.
Toxicology · 64d
Cleared May 27, 2004
DRI OXYCODONE ASSAY
K040411 · LAS
Microgenics Corp.
Toxicology · 99d
Cleared May 19, 2004
BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)
K033885 · DIS
Lin-Zhi International, Inc.
Toxicology · 156d
Cleared May 19, 2004
ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST...
K040445 · JXN
ACON Laboratories, Inc.
Toxicology · 89d
Cleared May 17, 2004
MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062
K033566 · DKZ
Rapid Diagnostics, Inc.
Toxicology · 187d
Cleared May 17, 2004
AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST
K040464 · LDJ
Amedica Biotech, Inc.
Toxicology · 84d
Cleared May 12, 2004
RANDOX AMPHETAMINE CLASS ASSAY
K040350 · DKZ
Randox Laboratories, Ltd.
Toxicology · 90d
Cleared May 10, 2004
RANDOX METHADONE ASSAY
K040570 · DJR
Randox Laboratories, Ltd.
Toxicology · 67d
Cleared May 05, 2004
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE,...
K040629 · LDJ
Accu-Stat Diagnostics, Inc.
Toxicology · 56d
Cleared May 03, 2004
ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE
K040274 · DJG
ACON Laboratories, Inc.
Toxicology · 88d
Cleared Apr 28, 2004
HEMOSONIC 200HEMODYNAMIC MONITOR
K040802 · DPN
Arrow Intl., Inc.
Toxicology · 30d
Cleared Apr 19, 2004
ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE...
K040327 · MVO
Accu-Stat Diagnostics, Inc.
Toxicology · 69d
Cleared Apr 07, 2004
CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST...
K033866 · DIO
Lin-Zhi International, Inc.
Toxicology · 117d
Cleared Apr 02, 2004
NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL)
K040352 · JJY
Bioresource Technology, Inc.
Toxicology · 50d
Cleared Mar 25, 2004
MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22
K040203 · DKZ
Branan Medical Corp.
Toxicology · 56d
Cleared Mar 08, 2004
AMEDITECH IMMU TEST DRUG SCREEN PANEL
K040092 · DKZ
Ameditech, Inc.
Toxicology · 52d
Cleared Mar 05, 2004
LABONE COCAINE METABOLITE MICRO-PLATE EIA
K040198 · DIO
Labone, Inc.
Toxicology · 36d
Cleared Feb 27, 2004
VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126
K033879 · DKB
Maine Standards Co.
Toxicology · 74d
Cleared Feb 20, 2004
DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG...
K033809 · KLR
Dade Behring, Inc.
Toxicology · 74d
Cleared Feb 17, 2004
ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST...
K032903 · DIO
ACON Laboratories, Inc.
Toxicology · 153d
Cleared Feb 17, 2004
ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST...
K033047 · DJG
ACON Laboratories, Inc.
Toxicology · 141d
Cleared Feb 13, 2004
ELECSYS C-PEPTIDE CALSET
K033873 · JIX
Roche Diagnostics Corp.
Toxicology · 60d
Cleared Feb 10, 2004
LABONE MICRO-PLATE COTININE EIA
K033601 · DLJ
Labone, Inc.
Toxicology · 88d