510(k) K032571 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Dec 24, 2003 |
| Received | Aug 20, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032571
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.