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
49–72 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Mar 08, 2024
Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
K231904 · DJG
Co-Innovation Biotech Co., Ltd.
Toxicology · 254d
Cleared Mar 06, 2024
FaStep Fentanyl Rapid Test Device (Urine)
K240351 · NGL
Assure Tech., LLC
Toxicology · 30d
Cleared Feb 27, 2024
ARK Levetiracetam II Assay
K232522 · ORI
ARK Diagnostics, Inc.
Toxicology · 193d
Cleared Feb 23, 2024
Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature...
K232228 · DJG
Shanghai Accurature Diagnostics Co.,...
Toxicology · 211d
Cleared Feb 20, 2024
ONLINE TDM Methotrexate
K233454 · LAO
Roche Diagnostics Operations
Toxicology · 123d
Cleared Jan 17, 2024
Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20,...
K232732 · LDJ
Co-Innovation Biotech Co., Ltd.
Toxicology · 132d
Cleared Jan 10, 2024
LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC)...
K232604 · LDJ
Hangzhou Laihe Biotech Co., Ltd.
Toxicology · 135d
Cleared Jan 09, 2024
LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test...
K232597 · DJG
Hangzhou Laihe Biotech Co., Ltd.
Toxicology · 134d
Cleared Dec 20, 2023
ARK Methotrexate II Assay
K232017 · LAO
ARK Diagnostics, Inc.
Toxicology · 166d
Cleared Dec 20, 2023
Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen...
K232736 · DJG
Chemtron Biotech, Inc.
Toxicology · 104d
Cleared Dec 13, 2023
Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
K232659 · DJG
Guangzhou Decheng Biotechnology Co.,...
Toxicology · 104d
Cleared Dec 13, 2023
AllTest Multi-Drug Rapid Test Cup
K233019 · DKZ
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 82d
Cleared Nov 17, 2023
Alinity c Tricyclic Antidepressants Reagent Kit
K231020 · LFH
Microgenics Corporation
Toxicology · 221d
Cleared Nov 02, 2023
BioSieveTM Multi-Drug Urine Test Panel
K233062 · NFT
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 37d
Cleared Oct 26, 2023
AllTest Fentanyl Urine Test Cassette
K233417 · NGL
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 16d
Cleared Oct 05, 2023
Evidence MultiSTAT DOA Urine MultiPlex
K221550 · DJG
Randox Laboratories Limited
Toxicology · 492d
Not Cleared Sep 29, 2023
Procise IFX
DEN210056 · QXT
Procisedx, Inc.
Toxicology · 660d
Not Cleared Sep 29, 2023
Procise ADL
DEN220023 · QYD
Procisedx, Inc.
Toxicology · 543d
Cleared Aug 31, 2023
BioSieve™ Marijuana Test Panel 50
K231978 · NFW
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 59d
Cleared Aug 08, 2023
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
K222439 · LEH
Siemens Healthcare Diagnostics, Inc.
Toxicology · 361d
Cleared Jul 31, 2023
AllTest Fentanyl Rapid Test (Urine)
K231698 · DJG
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 49d
Cleared Jul 25, 2023
Emit® II Plus Buprenorphine Assay
K221605 · DJG
Siemens Healthcare Diagnostics, Inc.
Toxicology · 418d
Cleared Jun 02, 2023
ADVIA Centaur® Anti-Müllerian Hormone (AMH)
K221801 · PQO
Siemens Healthcare Diagnostics, Inc.
Toxicology · 346d
Cleared May 19, 2023
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
K231137 · DKZ
Xenta Biomedical Science Co., Ltd.
Toxicology · 28d