510(k) K951542 ยท GTZ Antisera, All Groups, Streptococcus Spp.
DIRECTIGEN 1-2-3 GROUP A STREP TEST
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Columbus NE, US |
| Decision | Substantially Equivalent, Oct 20, 1995 |
| Received | Apr 3, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951542
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.