510(k) K112996 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
EUROIMMUN ANTI-ENA POOL ELISA (IGG)
| Applicant | Euroimmun US, Morris Plains NJ, US |
| Decision | Substantially Equivalent, Apr 9, 2013 |
| Received | Oct 7, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112996
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.