510(k) K915330 ยท GTJ Antisera, All Groups, N. Meningitidis
DIRECTIGEN MENINGITIS COMBO TEST KIT
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Mar 23, 1992 |
| Received | Nov 26, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915330
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.