510(k) K131185 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
ANA SCREEN ELISA (IGG)
| Applicant | Euroimmun US, Morris Plains NJ, US |
| Decision | Substantially Equivalent, Jul 15, 2013 |
| Received | Apr 26, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131185
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.