510(k) K113439 ยท NIY Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)
| Applicant | Euroimmun US, Morris Plains NJ, US |
| Decision | Substantially Equivalent, Apr 12, 2013 |
| Received | Nov 21, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113439
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.