510(k) K221869 ยท OYX Bcr/Abl1 Monitoring Test
BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
| Applicant | Suzhou Sniper Medical Technologies Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Sep 5, 2023 |
| Received | Jun 28, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221869
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.