510(k) K843713 ยท GTZ Antisera, All Groups, Streptococcus Spp.
DIRECTIGEN GROUP A STREP TEST KIT
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Washington DC, US |
| Decision | Substantially Equivalent, Jan 4, 1985 |
| Received | Sep 21, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K843713
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.