510(k) K142781 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA
| Applicant | Immco Diagnostics, Inc., Clarence NY, US |
| Decision | Substantially Equivalent, Mar 31, 2015 |
| Received | Sep 26, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142781
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.