510(k) K251697 · GTY Antigens, All Groups, Streptococcus Spp.
Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 26, 2025 |
| Received | Jun 2, 2025 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K251697
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.