510(k) K232377 ยท QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Healgen Rapid COVID-19 Antigen Test
| Applicant | Healgen Scientific,, LLC, Houston TX, US |
| Decision | Substantially Equivalent, Apr 19, 2024 |
| Received | Aug 8, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232377
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.