510(k) K063689 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
BD DIRECTIGEN EZ FLU A+B TEST
| Applicant | Becton, Dickinson & CO, Sparks MD, US |
| Decision | Substantially Equivalent, Mar 7, 2007 |
| Received | Dec 12, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063689
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.