510(k) K253839 ยท QVP Sars-Cov-2 Serology Test
Elecsys Anti-SARS-CoV-2
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 17, 2025 |
| Received | Dec 1, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253839
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.