510(k) K040095 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Mar 5, 2004 |
| Received | Jan 20, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040095
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.