510(k) K092736 ยท DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
EUROIMMUN ANTI-M2-3E ELISA (IGG)
| Applicant | Euroimmun Us, Inc., Morristown NJ, US |
| Decision | Substantially Equivalent, Sep 2, 2010 |
| Received | Sep 4, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092736
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.