510(k) K851132 ยท GTZ Antisera, All Groups, Streptococcus Spp.
LATEX AGGLUTINATION TEST
| Applicant | New Horizons Diagnostics Co., Columbia MD, US |
| Decision | Substantially Equivalent, Jul 5, 1985 |
| Received | Mar 21, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K851132
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.