510(k) K812808 ยท GTY Antigens, All Groups, Streptococcus Spp.
BBL DIRECTIGEN TEST KIT
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Washington DC, US |
| Decision | Substantially Equivalent, Dec 30, 1981 |
| Received | Oct 6, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812808
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.