FDA decided 14 premarket notifications (510(k)s) for clinical toxicology devices from 11 applicants in the last 12 months, newest first. Each row links to FDA's own record of the decision.
| Decided | Applicant | Device | Where | Record |
|---|---|---|---|---|
| 2026-09-10 | Bioteke Corporation (Wuxi) Co., Ltd. | BioTeke® Multi-Drug Urine Test Cup NFT | CN | K261409 |
| 2026-07-24 | Siemens Healthcare Diagnostics, Inc. | Atellica CH Acetaminophen 2 (ACTM) LDP | Tarrytown, New York | K261364 |
| 2026-07-17 | Assure Tech., LLC | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup NFT | Wilmington, Delaware | K261984 |
| 2026-05-22 | Vivachek Biotech (Hangzhou) Co., Ltd. | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel NFT | CN | K261280 |
| 2026-04-28 | Guangzhou Wondfo Biotech Co., Ltd. | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx NFT | CN | K260065 |
| 2026-03-16 | Healgen Scientific,, LLC | Healgen® Accurate Oral Fluid Drug Test DJC | Houston, Texas | K253705 |
| 2026-03-09 | WEBEST Biotech,, LLC | Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup NFT | Irwindale, California | K260355 |
| 2026-02-12 | Healgen Scientific,, LLC | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test NFW | Houston, Texas | K252523 |
| 2026-01-29 | Medtox Diagnostics, Inc. | Labcorp Fentanyl Urine Visual Test DJG | Burlington, North Carolina | K252684 |
| 2026-01-23 | Randox Laboratories Limited | Evidence MultiSTAT DOA Urine MultiPlex DJG | GB | K250741 |
| 2026-01-16 | Lin-Zhi International, Inc. | LZI Buprenorphine II Enzyme Immunoassay DJG | Santa Clara, California | K253082 |
| 2025-12-23 | Healgen Scientific,, LLC | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card NGL | Houston, Texas | K253567 |
| 2025-11-26 | Mgc Diagnostics Corporation | Fenom Flo FeNO Monitoring System MXA | St. Paul, Minnesota | K251674 |
| 2025-11-18 | Guangzhou Wondfo Biotech Co., Ltd. | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx NFT | CN | K252550 |
Where this comes from
Before most medical devices can be sold in the United States, the maker submits a premarket notification, a 510(k), and FDA decides whether the device is substantially equivalent to one already on the market. Every row here is one of those decisions, linked to FDA's own record of it. The product area is the medical specialty FDA files the device under; the location is the applicant's, as the submission gives it.
A clearance means the agency found the device substantially equivalent; it is not an endorsement. Where an applicant also files with the SEC under the same name in the same state, it links to that company's page.
All device clearancesFDA warning letters
Cite this page
https://mentionfox.com/fda/510k/clinical-toxicology