510(k) K254262 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA
| Applicant | Ortho Clinical Diagnostics Inc. (QuidelOrtho), San Diego CA, US |
| Decision | Substantially Equivalent, Sep 4, 2026 |
| Received | Dec 30, 2025 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K254262
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.