510(k) K181871 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay
| Applicant | Phadia AB, Uppsala, SE |
| Decision | Substantially Equivalent, Mar 1, 2019 |
| Received | Jul 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181871
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.