510(k) K233688 ยท QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set
| Applicant | Quidel Corporation, San Diego CA, US |
| Decision | Substantially Equivalent, Dec 13, 2023 |
| Received | Nov 17, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K233688
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.