510(k) K852841 ยท GTZ Antisera, All Groups, Streptococcus Spp.
RAPID DIRECT STREP A LATEX AGGLUTINATION TEST
| Applicant | Smithkline Diagnostics, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jul 24, 1985 |
| Received | Jul 5, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852841
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.