510(k) K884191 ยท GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION
| Applicant | Baxter Diagnostics, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Nov 22, 1988 |
| Received | Oct 6, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884191
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.