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
169–192 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Aug 15, 2017
Rapid Tox Cup II
K170222 · LAF
American Bio Medica Corp.
Toxicology · 202d
Cleared Aug 11, 2017
xTAG CYP2D6 Kit v3
K170492 · NTI
Luminex Molecular Diagnostics, Inc.
Toxicology · 175d
Cleared Aug 02, 2017
Healgen Multi-Drug Urine Test Cup
K163704 · JXM
Healgen Scientific, LLC
Toxicology · 216d
Cleared Jun 26, 2017
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100...
K170416 · DJR
Lin-Zhi International, Inc.
Toxicology · 136d
Cleared Jun 14, 2017
Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl...
K161216 · DJG
Immunalysis Corporation
Toxicology · 411d
Cleared Jun 02, 2017
MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup
K162395 · DIO
Mp Biomedicals, LLC
Toxicology · 280d
Not Cleared May 05, 2017
ARK Voriconazole II Assay Test System
DEN160033 · PUJ
ARK Diagnostics, Inc.
Toxicology · 294d
Cleared May 02, 2017
AssureTech Panel Dip Test, AssureTech Quick Cup Test
K170049 · NFT
Assure Tech. (Hangzhou) Co, Ltd.
Toxicology · 117d
Cleared Apr 06, 2017
CEDIA Buprenorphine II Assay
K163101 · DJG
Microgenics Corporation
Toxicology · 150d
Cleared Apr 06, 2017
Atellica CH Phencyclidine (Pcp)
K163220 · LCM
Siemens Healthcare Diagnostics, Inc.
Toxicology · 141d
Cleared Nov 18, 2016
Quest Diagnostics HairCheck-DT (Cocaine)
K152232 · DIO
Quest Diagnostics Incorporated
Toxicology · 469d
Cleared Oct 14, 2016
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug...
K161714 · DIS
Immunalysis Corporation
Toxicology · 115d
Cleared Aug 30, 2016
CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
K161251 · DKZ
Hangzhou Clongene Biotech Co., Ltd.
Toxicology · 119d
Cleared Aug 17, 2016
First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First...
K160793 · DJR
W.H.P.M., Inc.
Toxicology · 147d
Cleared Aug 09, 2016
ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator,...
K153596 · POX
ARK Diagnostics, Inc.
Toxicology · 237d
Cleared CT Jul 14, 2016
Soberlink Cellular Device and Sober Sky Web Portal
K160613 · DJZ
Soberlink Healthcare, LLC
Toxicology · 133d
Cleared Jul 06, 2016
AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key...
K161044 · DJC
Assure Tech. (Hangzhou) Co, Ltd.
Toxicology · 84d
Cleared Jun 27, 2016
Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine...
K161214 · DIO
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 59d
Cleared Jun 24, 2016
Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug...
K152122 · DKZ
Alfa Scientific Designs, Inc.
Toxicology · 330d
Cleared May 23, 2016
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K153597 · JXM
Healgen Scientific, LLC
Toxicology · 159d
Cleared May 03, 2016
UCP COMPACT DRUG TESTS
K152908 · DKZ
Ucp Biosciences, Inc.
Toxicology · 215d
Cleared Apr 27, 2016
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
K160202 · LEH
Siemens Healthcare Diagnostics, Inc.
Toxicology · 90d
Cleared Apr 26, 2016
Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
K153050 · DJG
Co-Innovation Biotech Co., Ltd.
Toxicology · 189d
Cleared Apr 18, 2016
Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel...
K153192 · DJG
Chemtron Biotech, Inc.
Toxicology · 167d