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
121–144 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Oct 04, 2019
LZI Methadone II Enzyme Immunoassay
K192433 · DJR
Lin-Zhi International, Inc.
Toxicology · 29d
Cleared Oct 03, 2019
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
K191099 · DKZ
Atlas Medical
Toxicology · 161d
Cleared Sep 20, 2019
BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip
K192301 · NFW
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology · 28d
Cleared Aug 16, 2019
SAFECARE® THC Urine Strip Test
K191924 · NFW
Safecare Biotech (Hangzhou) Co., Ltd.
Toxicology · 29d
Cleared Aug 07, 2019
Accurate Multi Panel Drug Urine Test Cup
K191841 · NFT
Healstone Biotech, Inc.
Toxicology · 29d
Cleared Jun 19, 2019
Quidel Triage TOX Drug Screen, 94600
K182719 · DKZ
Quidel Cardiovascular, Inc.
Toxicology · 264d
Cleared May 24, 2019
TruDiagnosis System
K183530 · ODW
Akonni Biosystems, Inc.
Toxicology · 156d
Cleared Apr 18, 2019
Psychemedics Microplate EIA for Fentanyl in Hair
K182103 · DJG
Psychemedics Corporation
Toxicology · 258d
Cleared Mar 29, 2019
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
K182123 · DJG
Advin Biotech, Inc.
Toxicology · 235d
Cleared Mar 27, 2019
Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and...
K182738 · DKZ
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 180d
Cleared Mar 21, 2019
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
K190412 · NGL
Hangzhou Clongene Biotech Co., Ltd.
Toxicology · 28d
Cleared Feb 08, 2019
SEKURE Acetaminophen L3K Assay
K180835 · LDP
Sekisui Diagnostics P.E.I., Inc.
Toxicology · 315d
Cleared Jan 24, 2019
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
K181135 · LCM
Immunalysis Corporation
Toxicology · 269d
Cleared Dec 17, 2018
BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid...
K180878 · DJC
Shanghai Venture Bio-Tech Co., Ltd.
Toxicology · 258d
Cleared Dec 14, 2018
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid...
K180879 · DKZ
Shanghai Venture Bio-Tech Co., Ltd.
Toxicology · 255d
Cleared Dec 10, 2018
ARK Tramadol Assay
K182280 · DJG
ARK Diagnostics, Inc.
Toxicology · 110d
Cleared Dec 03, 2018
LZI Fentanyl Enzyme Immunoassay
K181159 · DJG
Lin-Zhi International, Inc.
Toxicology · 216d
Cleared Dec 03, 2018
Wondfo T-Cup Multi-Drug Urine Test Cup
K182701 · NFT
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 67d
Cleared Nov 21, 2018
ARK EDDP Assay
K182779 · DJR
ARK Diagnostics, Inc.
Toxicology · 51d
Cleared Nov 19, 2018
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
K182654 · NGG
Safecare Biotech (Hangzhou) Co., Ltd.
Toxicology · 55d
Not Cleared Nov 19, 2018
QMS Plazomicin Immunoassay
DEN180030 · QDR
Microgenics Corporation
Toxicology · 147d
Cleared Nov 09, 2018
BIOEASY Multi-Drug Test Cup
K182530 · NFT
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology · 56d
Cleared Nov 06, 2018
Elecsys Tacrolimus
K173857 · MLM
Roche Diagnostics
Toxicology · 321d
Cleared Oct 31, 2018
Immunalysis Ethyl Alcohol Enzyme Assay
K181553 · DIC
Immunalysis Corporation
Toxicology · 140d