510(k) K250398 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Innovita Flu A/B Antigen Rapid Test
| Applicant | Innovita (Tangshan) Biological Technology Co., Ltd., Qian'An, CN |
| Decision | Substantially Equivalent, Jul 3, 2025 |
| Received | Feb 12, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250398
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.