510(k) K091520 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Mar 10, 2010 |
| Received | May 22, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091520
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.