510(k) K092601 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
IMMULISA ANCA SCREEN ELISA
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Oct 7, 2010 |
| Received | Aug 24, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092601
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.