510(k) K101461 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
BD DIRECTIGEN EX FLU A+B
| Applicant | Becton, Dickinson and Company, La Jolla CA, US |
| Decision | Substantially Equivalent, Jun 24, 2010 |
| Received | May 26, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101461
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.