510(k) K123182 ยท GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
OSOM INFLUENZA A&B TEST MODEL 190
| Applicant | SEKISUI Diagnostics, LLC, San Diego CA, US |
| Decision | Substantially Equivalent, Nov 5, 2012 |
| Received | Oct 10, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123182
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.