510(k) K163177 ยท MST Antibodies, Gliadin
ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA
| Applicant | Immco Diagnostics, Inc., Clarence NY, US |
| Decision | Substantially Equivalent, Jul 28, 2017 |
| Received | Nov 14, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163177
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.