510(k) K193604 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
Aptiva Celiac Disease IgA Reagent
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 16, 2021 |
| Received | Dec 23, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193604
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.