FDA decided 1 premarket notifications (510(k)s) for medical genetics devices from 1 applicants in the last 12 months, newest first. Each row links to FDA's own record of the decision.
| Decided | Applicant | Device | Where | Record |
|---|---|---|---|---|
| 2026-07-02 | Suzhou Precigenome, Ltd. Co; | Fastplex BCR-ABL (p210) %IS digital PCR Kit OYX | CN | K252243 |
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/medical-genetics