510(k) K854978 ยท GTZ Antisera, All Groups, Streptococcus Spp.
DIFCO STREP A LATEX TEST
| Applicant | Difco Laboratories, Inc., Detroit MI, US |
| Decision | Substantially Equivalent, Mar 18, 1986 |
| Received | Dec 12, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854978
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.