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
1–24 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Sep 10, 2026
BioTeke® Multi-Drug Urine Test Cup
K261409 · NFT
Bioteke Corporation (Wuxi) Co., Ltd.
Toxicology · 133d
Cleared Jul 17, 2026
AssureTech Quick Cup Tests
K261984 · NFT
Assure Tech., LLC
Toxicology · 35d
Cleared May 22, 2026
BioSieve Multi-Drug Urine Test Panel
K261280 · NFT
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 35d
Cleared Apr 28, 2026
SAFElife T-Dip Multi-Drug Urine Test Panel
K260065 · NFT
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 109d
Cleared Mar 16, 2026
Healgen® Accurate Oral Fluid Drug Test
K253705 · DJC
Healgen Scientific, LLC
Toxicology · 112d
Cleared Mar 09, 2026
Webest Multi-Drug Urine Cup
K260355 · NFT
WEBEST Biotech,, LLC
Toxicology · 34d
Cleared Feb 12, 2026
Healgen® Accurate Oral Fluid Drug Test COT/THC
K252523 · NFW
Healgen Scientific, LLC
Toxicology · 185d
Cleared Jan 29, 2026
Labcorp Fentanyl Urine Visual Test
K252684 · DJG
Medtox Diagnostics, Inc.
Toxicology · 157d
Cleared Jan 23, 2026
Evidence MultiSTAT DOA Urine MultiPlex
K250741 · DJG
Randox Laboratories Limited
Toxicology · 318d
Cleared Jan 16, 2026
LZI Buprenorphine II Enzyme Immunoassay
K253082 · DJG
Lin-Zhi International, Inc.
Toxicology · 115d
Cleared Dec 23, 2025
Healgen Accurate Urine Drug Screen Dip Card
K253567 · NGL
Healgen Scientific, LLC
Toxicology · 36d
Cleared Nov 18, 2025
SAFElife T-Cup Multi-Drug Urine Test Cup
K252550 · NFT
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 97d
Cleared Oct 09, 2025
VINScreen Urine Drug Test Cup
K252867 · NFT
Advin Biotech, Inc.
Toxicology · 30d
Cleared Sep 15, 2025
Sober Self-Test
K250609 · DIC
Sober Ip, LLC
Toxicology · 199d
Cleared Sep 12, 2025
Wisdiag Multi-Drug Urine Test Cup
K252554 · NFT
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 30d
Cleared Sep 11, 2025
SEFRIA™ Hydrocodone Oral Fluid
K252520 · DJG
Immunalysis Corporation
Toxicology · 31d
Cleared Aug 27, 2025
CLUNGENE Multi-Drug Test Easy Cup
K252118 · NFT
Hangzhou Clongene Biotech Co., Ltd.
Toxicology · 51d
Cleared Aug 15, 2025
AssureTech Quick Cup Tests
K252259 · NFT
Assure Tech., LLC
Toxicology · 25d
Cleared Aug 15, 2025
Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative
K251972 · DJG
Healgen Scientific, LLC
Toxicology · 50d
Cleared Jul 09, 2025
ARCHITECT iGentamicin
K243500 · LCD
Abbott Laboratories
Toxicology · 239d
Cleared Jun 18, 2025
LZI Fentanyl III Enzyme Immunoassay
K251634 · DJG
Lin-Zhi International, Inc.
Toxicology · 20d
Cleared Apr 15, 2025
Deepblue Multi-Drug Urine Test Cup
K250803 · NGL
Anhui Deepblue Medical Technological...
Toxicology · 29d
Cleared Apr 04, 2025
AllTest Multi-Drug Rapid Urine Test Cup
K250727 · NFT
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 24d
Cleared Mar 18, 2025
LYHER® Oral fluid Multi-Drug Test Kit (Cube)
K240287 · DJC
Hangzhou Laihe Biotech Co., Ltd.
Toxicology · 411d