510(k) K143736 ยท DHR System, Test, Rheumatoid Factor
ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA
| Applicant | Immco Diagnostics, Inc., Clarence NY, US |
| Decision | Substantially Equivalent, Sep 23, 2015 |
| Received | Dec 30, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143736
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.