510(k) K845022 ยท GTZ Antisera, All Groups, Streptococcus Spp.
PATHO DX LATEX AGGLUTINATION STREP B KIT
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, May 2, 1985 |
| Received | Dec 27, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K845022
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.