510(k) K001364 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
BD DIRECTIGEN FLU A+B
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Sparks MD, US |
| Decision | Substantially Equivalent, Jun 28, 2000 |
| Received | May 1, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001364
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.