510(k) K042472 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
BD DIRECTIGEN EZ FLU A + B
| Applicant | Becton, Dickinson & CO, San Diego CA, US |
| Decision | Substantially Equivalent, Jul 7, 2005 |
| Received | Sep 10, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042472
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.