510(k) K131804 ยท GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
REMEL XPECT FLU A&B
| Applicant | Remel, Inc., Lenexa KS, US |
| Decision | Substantially Equivalent, Jul 12, 2013 |
| Received | Jun 19, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131804
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.