510(k) K181556 ยท DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
EliA M2 Immunoassay
| Applicant | Phadia AB, Uppsala, SE |
| Decision | Substantially Equivalent, Jul 13, 2018 |
| Received | Jun 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181556
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.