510(k) K863908 ยท GTZ Antisera, All Groups, Streptococcus Spp.
BINAX STREP A
| Applicant | Binax, Inc., S. Portland ME, US |
| Decision | Substantially Equivalent, Dec 22, 1986 |
| Received | Oct 7, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863908
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.