510(k) K252243 · OYX Bcr/Abl1 Monitoring Test
Fastplex BCR-ABL (p210) %IS digital PCR Kit
| Applicant | Suzhou Precigenome, Ltd. Co;, Suzhou, CN |
| Decision | Substantially Equivalent, Jul 2, 2026 |
| Received | Jul 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252243
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.