510(k) K860768 ยท GTZ Antisera, All Groups, Streptococcus Spp.
DIRECTIGEN COMBO MENINGITIS TEST
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Paramus NJ, US |
| Decision | Substantially Equivalent, May 13, 1986 |
| Received | Mar 3, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860768
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.