510(k) K112221 ยท NIY Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
EUROIMMUN ANTI-SLA/LP ELISA(LGG)
| Applicant | Euroimmun US, Morris Plains NJ, US |
| Decision | Substantially Equivalent, Sep 11, 2012 |
| Received | Aug 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112221
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.