510(k) K092423 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
XPECT FLU A & B
| Applicant | Thermo Fisher Scientific, Lenexa KS, US |
| Decision | Substantially Equivalent, Aug 26, 2009 |
| Received | Aug 7, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092423
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.