510(k) K182001 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Acucy Influenza A&B Test with the Acucy System
| Applicant | SEKISUI Diagnostics, LLC, San Diego CA, US |
| Decision | Substantially Equivalent, Dec 17, 2018 |
| Received | Jul 26, 2018 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K182001
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.