510(k) K982898 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Nov 30, 1998 |
| Received | Aug 17, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982898
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.