510(k) K161258 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 3, 2017 |
| Received | May 4, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161258
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.