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
25–48 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Feb 27, 2025
AllTest Multi-Drug Rapid Test Cup
K244043 · NFT
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 59d
Cleared Feb 20, 2025
Dochek® Multi-Drug Urine Test Cup
K250067 · NGL
Guangzhou Decheng Biotechnology Co.,...
Toxicology · 41d
Cleared Feb 07, 2025
AssureTech Panel Dip Tests
K243996 · NFT
Assure Tech., LLC
Toxicology · 43d
Cleared Feb 06, 2025
Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus,...
K242428 · NGL
Guangzhou Decheng Biotechnology Co.,...
Toxicology · 175d
Cleared Dec 17, 2024
Healgen Accurate Muti-Drug Urine Drug Screen Cup
K243365 · NGL
Healgen Scientific, LLC
Toxicology · 49d
Cleared Dec 11, 2024
Alinity c Benzodiazepines Reagent Kit
K243498 · JXM
Microgenics Corporation
Toxicology · 29d
Cleared Nov 20, 2024
ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold)
K243064 · NGL
Eterbio, Inc.
Toxicology · 54d
Cleared Nov 08, 2024
CLUNGENE Fentanyl Home Test Cassette
K242802 · NGL
Hangzhou Clongene Biotech Co., Ltd.
Toxicology · 52d
Cleared Oct 30, 2024
DRI Ecstasy Plus Assay
K240670 · DKZ
Microgenics Corporation
Toxicology · 233d
Cleared Oct 04, 2024
BioSieve™ Fentanyl FIA Home Test Kit
K241869 · NGL
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 99d
Cleared Oct 01, 2024
Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC
K242498 · NFT
Aicheck Biotech, Inc.
Toxicology · 40d
Cleared Sep 27, 2024
AllTest Multi-Drug Urine Test Panel
K242540 · NFT
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 32d
Cleared Aug 14, 2024
PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup
K242077 · NFT
Aicheck Biotech, Inc.
Toxicology · 29d
Cleared Aug 14, 2024
Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel
K241969 · NGL
Qingdao Hightop Biotech Co., Ltd.
Toxicology · 40d
Cleared Jul 16, 2024
SAFElife™ Fentanyl Urine Home Test (Cassette)
K241741 · NGL
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 29d
Cleared Jun 17, 2024
AllTest Multi-Drug Urine Test Cup
K241428 · NFT
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 28d
Cleared Jun 14, 2024
BioSieve™ Fentanyl FIA Test Kit
K240124 · DJG
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 150d
Cleared May 22, 2024
Rapid Urine Fentanyl (FYL) Test Strip
K241100 · NGL
Co-Innovation Biotech Co., Ltd.
Toxicology · 30d
Cleared May 13, 2024
Healgen® Accurate Fentanyl Rapid Test Cassette (Urine)
K240949 · NGL
Healgen Scientific, LLC
Toxicology · 35d
Cleared May 10, 2024
Dochek® Multi-Drug Urine Test Dipcard Rx
K240698 · DJG
Guangzhou Decheng Biotechnology Co.,...
Toxicology · 57d
Cleared Apr 12, 2024
Healgen Accurate Urine Drug Screen Dip Card
K240686 · NGL
Healgen Scientific, LLC
Toxicology · 31d
Cleared Apr 10, 2024
SAFECARE Fentanyl Urine Test Cassette
K240654 · NGL
Safecare Biotech (Hangzhou) Co., Ltd.
Toxicology · 34d
Cleared Mar 28, 2024
InstaStrip Fentanyl Rapid Test (Urine)
K240295 · NGL
Instanosis, Inc.
Toxicology · 56d
Cleared Mar 21, 2024
AllSource Drug Detector FenTest
K234006 · NGL
Allsource Screening Solutions
Toxicology · 93d