510(k) K874761 ยท GTZ Antisera, All Groups, Streptococcus Spp.
RAPID COLORIMETRIC DIRECT STREP A TEST
| Applicant | New Horizons Diagnostics Co., Columbia MD, US |
| Decision | Substantially Equivalent, Feb 19, 1988 |
| Received | Nov 19, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K874761
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.