510(k) K140224 ยท LKO Anti-Rnp Antibody, Antigen And Control
EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)
| Applicant | Euroimmun US, Morris Plains NJ, US |
| Decision | Substantially Equivalent, Dec 9, 2014 |
| Received | Jan 29, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140224
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.