510(k) K971494 ยท GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES
| Applicant | Zymetx, Inc., Oklahoma City OK, US |
| Decision | Substantially Equivalent, Sep 10, 1997 |
| Received | Apr 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971494
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.