510(k) K151559 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
ImmuLisa Enhanced Centromere Antibody ELISA
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Mar 11, 2016 |
| Received | Jun 10, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151559
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.