510(k) K163525 ยท DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Sep 5, 2017 |
| Received | Dec 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163525
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.