510(k) K250377 ยท SCA Multi-Analyte Respiratory Virus Antigen Detection Test
Flowflex Plus COVID-19 + Flu A/B Home Test
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, May 10, 2025 |
| Received | Feb 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250377
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.