510(k) K150155 ยท DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
NOVA Lite DAPI ANA Kit
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 8, 2015 |
| Received | Jan 23, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150155
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.