510(k) K870155 ยท GTZ Antisera, All Groups, Streptococcus Spp.
DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Mar 10, 1987 |
| Received | Jan 13, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K870155
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.