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
97–120 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jul 16, 2021
ADVIA Centaur® Digoxin assay
K193397 · KXT
Siemens Healthcare Diagnostics, Inc.
Toxicology · 588d
Cleared CT Jun 30, 2021
Pivot Breath Sensor
K201206 · CCJ
Carrot, Inc.
Toxicology · 422d
Cleared Jun 25, 2021
Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair
K201228 · JXO
Psychemedics Corporation
Toxicology · 414d
Cleared Apr 20, 2021
SEFRIA PCP Oral Fluid Enzyme Immunoassay
K203489 · LCM
Immunalysis Corporation
Toxicology · 144d
Cleared Mar 24, 2021
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
K202453 · NFT
Safecare Biotech (Hangzhou) Co., Ltd.
Toxicology · 209d
Cleared Jan 15, 2021
IMMULITE® 2000 Cortisol
K202826 · CGR
Siemens Healthcare Diagnostics...
Toxicology · 113d
Cleared Sep 25, 2020
Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test...
K202567 · NFT
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 21d
Cleared Sep 17, 2020
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
K201494 · DJG
Advin Biotech, Inc.
Toxicology · 104d
Cleared Sep 17, 2020
LZI Oxycodone III Enzyme Immunoassay
K202007 · DJG
Lin-Zhi International, Inc.
Toxicology · 58d
Cleared Jul 31, 2020
Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for...
K201442 · LAF
Diatron Group
Toxicology · 60d
Cleared Jun 04, 2020
LZI Tramadol Enzyme Immunoassay
K201223 · DJG
Lin-Zhi International, Inc.
Toxicology · 29d
Cleared May 27, 2020
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
K201120 · NFT
Safecare Biotech (Hangzhou) Co., Ltd.
Toxicology · 30d
Cleared Apr 22, 2020
Psychemedics Microplate EIA for Cotinine in Hair
K192517 · MKU
Psychemedics Corporation
Toxicology · 222d
Not Cleared Apr 16, 2020
MyCare Psychiatry Clozapine Assay Kit
DEN190028 · QKT
Saladax Biomedical, Inc.
Toxicology · 328d
Cleared Mar 12, 2020
Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
K191638 · DIO
Medtest DX
Toxicology · 267d
Cleared Mar 11, 2020
Quidel Triage® TOX Drug Screen, 94600
K200363 · DKZ
Quidel Cardiovascular, Inc.
Toxicology · 26d
Cleared Feb 26, 2020
ARK Fentanyl II Assay
K200197 · DJG
ARK Diagnostics, Inc.
Toxicology · 30d
Cleared Feb 21, 2020
Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL...
K191030 · PCA
Life Technologies Corporation
Toxicology · 309d
Cleared Jan 31, 2020
BIOEASY Multi-Drug Test Cup
K193480 · NGL
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology · 46d
Cleared Dec 16, 2019
CEDIA Heroin Metabolite (6-AM) assay
K192943 · DJG
Microgenics Corporation
Toxicology · 59d
Cleared Dec 09, 2019
CEDIA Benzodiazepine Assay
K190968 · JXM
Microgenics Corporation
Toxicology · 241d
Cleared Nov 21, 2019
LZI Cotinine II Enzyme Immunoassay
K192299 · MKU
Lin-Zhi International, Inc.
Toxicology · 90d
Cleared Nov 15, 2019
Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
K190397 · QBK
Immunalysis Corporation
Toxicology · 269d
Cleared Oct 11, 2019
BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20,...
K192515 · LDJ
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology · 28d