510(k) K253882 ยท QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
CorDx Tyfast COVID-19 Ag Rapid Test Rx
| Applicant | CorDx, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Jun 1, 2026 |
| Received | Dec 4, 2025 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K253882
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.