510(k) K230828 ยท QYT Over-The-Counter Covid-19 Antigen Test
Flowflex COVID-19 Antigen Home Test
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 9, 2023 |
| Received | Mar 27, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230828
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.