510(k) K251916 ยท QYT Over-The-Counter Covid-19 Antigen Test
GenBody COVID-19 Ag Home Test
| Applicant | Genbody.Inc., Cheonan-Si, KR |
| Decision | Substantially Equivalent, Mar 13, 2026 |
| Received | Jun 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251916
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.