510(k) K854447 ยท GTZ Antisera, All Groups, Streptococcus Spp.
IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST
| Applicant | American Micro Scan, Sacramento CA, US |
| Decision | Substantially Equivalent, Jan 3, 1986 |
| Received | Nov 5, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854447
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.