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
145–168 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Not Cleared Oct 24, 2018
picoAMH ELISA
DEN180004 · QDH
Ansh Labs, LLC
Toxicology · 275d
Cleared Oct 18, 2018
QuickScreen Pro Multi Drug Screening Test, Model 9395Z
K181945 · DKZ
Phamatech, Inc.
Toxicology · 90d
Cleared Sep 20, 2018
OralTox Oral fluid Drug Test
K181305 · DJC
Premier Biotech, Inc.
Toxicology · 126d
Cleared Aug 20, 2018
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
K181768 · NFT
Assure Tech. (Hangzhou) Co, Ltd.
Toxicology · 48d
Cleared Aug 20, 2018
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
K181968 · NFT
Safecare Biotech (Hangzhou) Co., Ltd.
Toxicology · 27d
Cleared Jul 26, 2018
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
K181790 · NGL
Hangzhou Clongene Biotech Co., Ltd.
Toxicology · 21d
Cleared Jul 06, 2018
DRI Cocaine Metabolite Assay
K181499 · DIO
Microgenics Corporation
Toxicology · 29d
Cleared Jun 06, 2018
ARK Fentanyl Assay
K180427 · DJG
ARK Diagnostics, Inc.
Toxicology · 110d
Not Cleared Apr 20, 2018
LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
DEN170010 · QBK
Lin-Zhi International, Inc.
Toxicology · 423d
Cleared Apr 19, 2018
Synermed Opiate Enzyme Immunoassay
K172416 · DJG
Infrared Laboratory Systems, LLC (Dba...
Toxicology · 252d
Cleared Apr 05, 2018
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
K180349 · NFT
Assure Tech. (Hangzhou) Co, Ltd.
Toxicology · 56d
Cleared Feb 28, 2018
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
K180255 · PTH
Hangzhou Clongene Biotech Co., Ltd.
Toxicology · 29d
Cleared Feb 23, 2018
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use),...
K173303 · DKZ
Alfa Scientific Designs, Inc.
Toxicology · 128d
Cleared Feb 21, 2018
DRI Benzodiazepine Assay
K173963 · JXM
Microgenics Corporation
Toxicology · 55d
Cleared Feb 13, 2018
DRI Hydrocodone Assay
K173195 · DJG
Microgenics Corporation
Toxicology · 134d
Cleared Feb 05, 2018
First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First...
K171695 · NFT
W.H.P.M., Inc.
Toxicology · 243d
Cleared Feb 02, 2018
OralTox Oral Fluid Drug Test
K171403 · DJC
Premier Biotech, Inc.
Toxicology · 266d
Cleared Nov 22, 2017
CEDIA Heroin Metabolite (6-AM) Assay
K173183 · DJG
Microgenics Corporation
Toxicology · 51d
Cleared Oct 25, 2017
Emit II Plus Cocaine Metabolite Assay
K170293 · DIO
Siemens Healthcare Diagnostics, Inc.
Toxicology · 267d
Cleared Oct 18, 2017
Emit II Plus Oxycodone Assay
K172910 · DJG
Siemens Healthcare Diagnostics, Inc.
Toxicology · 23d
Cleared CT Sep 29, 2017
Carbon Monoxide Breath Sensor System (COBSS)
K171408 · CCJ
Carrot Sense, Inc.
Toxicology · 140d
Cleared Sep 15, 2017
Psychemedics Microplate EIA for Benzodiazepines in Hair
K163590 · JXM
Psychemedics Corporation
Toxicology · 269d
Cleared Aug 18, 2017
ARK Methotrexate Assay
K163359 · LAO
ARK Diagnostics, Inc.
Toxicology · 261d
Cleared Aug 15, 2017
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
K163570 · DIO
Carolina Liquid Chemistries Corporation
Toxicology · 239d