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
337–360 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Aug 02, 2010
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
K100200 · LDP
Siemens Healthcare Diagnostics
Toxicology · 189d
Cleared Jul 12, 2010
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE
K101059 · LCM
Omega Laboratories, Inc.
Toxicology · 88d
Cleared Jul 06, 2010
INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT...
K100051 · DJG
Alfa Scientific Designs, Inc.
Toxicology · 179d
Cleared Apr 05, 2010
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM
K100023 · DJG
Medtox Diagnostics, Inc.
Toxicology · 90d
Cleared Mar 02, 2010
U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD...
K092902 · NBW
Taidoc Technology Corporation
Toxicology · 162d
Cleared Feb 24, 2010
UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST
K091612 · DJG
Ucp Biosciences, Inc.
Toxicology · 266d
Cleared Feb 01, 2010
EC50 MICRO+ SMOKERLYZER
K082315 · CCJ
Bedfont Scientific, Ltd.
Toxicology · 537d
Cleared Jan 28, 2010
MISSION BREATH ALCOHOL DETECTOR
K093143 · DJZ
ACON Laboratories, Inc.
Toxicology · 115d
Cleared Dec 09, 2009
ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO,...
K091884 · NWM
ARK Diagnostics, Inc.
Toxicology · 168d
Cleared Nov 18, 2009
ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579
K091714 · DJZ
Skyfine Inc. Limited
Toxicology · 161d
Cleared Nov 17, 2009
CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS
K080459 · LAS
Chromsystems Instruments & Chemicals...
Toxicology · 636d
Cleared Nov 02, 2009
ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM...
K091653 · ORI
ARK Diagnostics, Inc.
Toxicology · 146d
Cleared Aug 20, 2009
BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP
K082977 · LDJ
Mk Bio, Inc.
Toxicology · 318d
Cleared Jul 30, 2009
BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS
K090844 · DJG
Lin-Zhi International, Inc.
Toxicology · 125d
Cleared Jul 24, 2009
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM
K091454 · DJG
Medtox Diagnostics, Inc.
Toxicology · 67d
Cleared Jul 17, 2009
QMS LIDOCAINE CALIBRATORS, MODEL 0374678
K091617 · DLJ
Thermo Fisher Scientific
Toxicology · 44d
Cleared Jun 01, 2009
ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771
K090900 · DKB
Siemens Healthcare Diagnostics
Toxicology · 61d
Cleared May 29, 2009
QMS LIDOCAINE
K090282 · KLR
Thermo Fisher Scientific, Inc.
Toxicology · 113d
Cleared May 01, 2009
ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
K081938 · LDP
Genzyme Diagnostics P.E.I., Inc.
Toxicology · 297d
Cleared Apr 16, 2009
TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL,...
K083799 · NWM
ARK Diagnostics, Inc.
Toxicology · 115d
Cleared Apr 01, 2009
ALCO TUBE PLUS
K082080 · DJZ
Alcotest Quebec
Toxicology · 252d
Cleared Mar 30, 2009
EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT,...
K083487 · NRP
Siemens Healthcare Diagnostics
Toxicology · 125d
Cleared Mar 24, 2009
BACTRACK SELECT BREATHALYZER, MODEL S80
K090067 · DJZ
Khn Solutions, LLC
Toxicology · 74d
Cleared Mar 19, 2009
BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70
K083801 · DJZ
Khn Solutions, LLC
Toxicology · 87d