510(k) K241188 · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Acucy® Influenza A&B Test with the Acucy® 2 System
| Applicant | SEKISUI Diagnostics, LLC, San Diego CA, US |
| Decision | Substantially Equivalent, Apr 18, 2025 |
| Received | Apr 29, 2024 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K241188
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.