510(k) K233358 ยท QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
SCoV-2 Ag Detect Rapid Test
| Applicant | InBios International, Inc., Seattle WA, US |
| Decision | Substantially Equivalent, Aug 23, 2024 |
| Received | Sep 29, 2023 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K233358
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.