510(k) K260095 ยท QYT Over-The-Counter Covid-19 Antigen Test
Heal-Check Rapid COVID-19 Antigen Self-Test
| Applicant | Healgen Scientific,, LLC, Houston TX, US |
| Decision | Substantially Equivalent, Apr 13, 2026 |
| Received | Jan 13, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260095
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.