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
217–240 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jul 01, 2015
Wondfo CR3 Keyless Split Sample Cup
K151478 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 29d
Cleared Jun 29, 2015
Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis...
K150925 · DIO
Immunalysis Corporation
Toxicology · 84d
Cleared Jun 05, 2015
Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine...
K151203 · LDJ
Immunalysis Corporation
Toxicology · 31d
Cleared Jun 04, 2015
AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech...
K151211 · DIS
Assure Tech. Co., Ltd.
Toxicology · 29d
Cleared May 28, 2015
LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids...
K141320 · LDJ
Lin-Zhi International, Inc.
Toxicology · 373d
Cleared May 20, 2015
RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE...
K141748 · DKZ
Biophor Diagnostics, Inc.
Toxicology · 324d
Cleared May 20, 2015
Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine...
K143502 · DJG
Immunalysis Corporation
Toxicology · 161d
Cleared Apr 24, 2015
Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen...
K150791 · DIS
Healgen Scientific, LLC
Toxicology · 30d
Cleared Apr 17, 2015
Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000
K143599 · DJG
Chemtron Biotech, Inc.
Toxicology · 120d
Cleared Apr 07, 2015
CR3 Keyless Split Sample Cup Morphine - Methamphetamine
K150602 · DNK
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 28d
Cleared Mar 09, 2015
Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis...
K150275 · DJG
Immunalysis Corporation
Toxicology · 33d
Cleared Mar 04, 2015
Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen...
K150096 · LAF
Healgen Scientific, LLC
Toxicology · 43d
Cleared Feb 25, 2015
CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids
K150179 · DJG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 29d
Cleared Feb 13, 2015
LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID...
K141205 · DJG
Lin-Zhi International, Inc.
Toxicology · 280d
Cleared Feb 12, 2015
IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY
K141803 · DJG
Immunalysis Corporation
Toxicology · 224d
Cleared Feb 06, 2015
Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine...
K143500 · DKZ
Immunalysis Corporation
Toxicology · 58d
Cleared Jan 08, 2015
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND...
K140671 · DJG
Omega Laboratories, Inc.
Toxicology · 296d
Cleared Dec 18, 2014
CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine
K142609 · LFG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 93d
Cleared Dec 11, 2014
Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard
K142800 · DKZ
Co-Innovation Biotech Co., Ltd.
Toxicology · 73d
Cleared Dec 08, 2014
GenPrime Snap-Top Split Key Cup
K140665 · DIS
Genprime, Inc.
Toxicology · 265d
Cleared Dec 01, 2014
Chemtrue Multi-Panel DOA DIP Card Tests
K142580 · DKZ
Chemtron Biotech, Inc.
Toxicology · 77d
Cleared Oct 09, 2014
Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests
K142396 · DJG
Chemtron Biotech, Inc.
Toxicology · 43d
Cleared Oct 07, 2014
First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test
K142353 · DIO
W.H.P.M., Inc.
Toxicology · 47d
Cleared Sep 25, 2014
FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup),...
K142408 · LDJ
Polymed Therapeutics, Inc.
Toxicology · 28d