510(k) K123713 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Oct 25, 2013 |
| Received | Dec 4, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123713
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.