510(k) K251753 ยท QYT Over-The-Counter Covid-19 Antigen Test
GenaCheck COVID-19 Rapid Self-Test
| Applicant | Genabio Diagnostics, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Sep 5, 2025 |
| Received | Jun 9, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251753
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.