510(k) K831991 ยท GTZ Antisera, All Groups, Streptococcus Spp.
DIRECTIGEN GROUP B STREP TEST KIT-SERUM
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Walker MI, US |
| Decision | Substantially Equivalent, Sep 26, 1983 |
| Received | Jun 21, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831991
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.