510(k) K010289 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
SCIMEDX PHASE II MPO IGG ANTIBODY EIA
| Applicant | Scimedx Corp., Denvill NJ, US |
| Decision | Substantially Equivalent, Mar 7, 2001 |
| Received | Jan 31, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010289
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.