510(k) K163133 ยท DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA
| Applicant | Immco Diagnostics, Inc., Clarence NY, US |
| Decision | Substantially Equivalent, Aug 8, 2017 |
| Received | Nov 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163133
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.