510(k) K251595 ยท QYT Over-The-Counter Covid-19 Antigen Test
COVID-19 Detect Rapid Self -Test
| Applicant | InBios International, Inc., Seattle WA, US |
| Decision | Substantially Equivalent, Oct 12, 2025 |
| Received | May 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251595
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.