510(k) K200230 ยท MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
Aptiva Celiac Disease IgG Reagent
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 26, 2021 |
| Received | Jan 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200230
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.