510(k) K952791 ยท GTJ Antisera, All Groups, N. Meningitidis
DIRECTIGEN MENINGITIS COMBO TEST
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Cockeysville MD, US |
| Decision | Substantially Equivalent, May 30, 1996 |
| Received | Jun 19, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952791
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.