510(k) K141375 ยท DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250
| Applicant | Phadia US, Inc., Freiburg Im Breisgau, DE |
| Decision | Substantially Equivalent, Feb 13, 2015 |
| Received | May 27, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141375
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.