510(k) K052262 ยท DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
QUANTA LITE M2 EP (MIT3) ELISA
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 27, 2005 |
| Received | Aug 19, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052262
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.