510(k) K183313 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)
| Applicant | Euroimmun Us, Inc., Mountain Lakes NJ, US |
| Decision | Substantially Equivalent, Feb 28, 2019 |
| Received | Nov 29, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183313
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.