510(k) K253971 ยท SIA Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test
Visby Medical Flu and COVID-19 Test
| Applicant | Visby Medical, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, May 27, 2026 |
| Received | Dec 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253971
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.