510(k) K112545 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 31, 2012 |
| Received | Sep 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112545
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.