510(k) K123880 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
QUANTA FLASH CENTROMERE
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 7, 2014 |
| Received | Dec 17, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123880
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.