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

193–216 of 3,029

Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology

Cleared Apr 15, 2016

ACCU NEWS Drug Screening Test Card/Urine Cup

Coretests, Inc.

Toxicology · 218d

Cleared Mar 31, 2016

AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split...

Assure Tech. (Hangzhou) Co, Ltd.

Toxicology · 121d

Cleared Mar 18, 2016

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine...

Safecare Biotech (Hangzhou) Co., Ltd.

Toxicology · 88d

Cleared Mar 18, 2016

Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug...

Immunalysis Corporation

Toxicology · 86d

Cleared Mar 18, 2016

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test

Hangzhou Clongene Biotech Co., Ltd.

Toxicology · 81d

Cleared Feb 23, 2016

Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control...

Biochemical Diagnostics, Inc.

Toxicology · 83d

Cleared Jan 05, 2016

Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug...

Immunalysis Corporation

Toxicology · 189d

Cleared Nov 23, 2015

Wondfo Propoxyphene Urine Test

Guangzhou Wondfo Biotech Co., Ltd.

Toxicology · 83d

Cleared Nov 09, 2015

First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse...

Toxicology · 62d

Cleared Nov 04, 2015

Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus...

Siemens Healthcare Diagnostics

Toxicology · 282d

Cleared Nov 02, 2015

EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine...

Nantong Egens Biotech Co., Ltd.

Toxicology · 48d

Cleared Oct 23, 2015

Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug...

Siemens Healthcare Diagnostics, Inc.

Toxicology · 227d

Cleared Oct 22, 2015

Carbamazepine Gen 4

Roche Diagnostics Operations (Rdo)

Toxicology · 133d

Cleared Sep 18, 2015

Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid...

Biophor Diagnostics, Inc.

Toxicology · 396d

Cleared Sep 09, 2015

PAXgene Blood DNA Tube

Preanalytix GmbH

Toxicology · 344d

Cleared Sep 09, 2015

Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine...

Healgen Scientific, LLC

Toxicology · 29d

Cleared Sep 04, 2015

Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

Immunalysis Corporation

Toxicology · 31d

Cleared Aug 21, 2015

UCP Drug Test Mini Cups

Ucp Biosciences, Inc.

Toxicology · 107d

Cleared Aug 18, 2015

Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen...

Healgen Scientific, LLC

Toxicology · 90d

Cleared Jul 28, 2015

Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3,...

Omega Laboratories, Inc.

Toxicology · 301d

Cleared Jul 24, 2015

RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE...

Biophor Diagnostics, Inc.

Toxicology · 354d

Cleared Jul 24, 2015

Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine...

Immunalysis Corporation

Toxicology · 59d

Cleared Jul 16, 2015

EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine...

Nantong Egens Biotech Co., Ltd.

Toxicology · 36d

Cleared Jul 07, 2015

LeadCare Plus Blood Lead Testing System

Magellan Diagnostics

Toxicology · 288d