K112221 is an FDA 510(k) clearance for the EUROIMMUN ANTI-SLA/LP ELISA(LGG). This device is classified as a Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis (Class II - Special Controls, product code NIY).
Submitted by Euroimmun US (Morris Plains, US). The FDA issued a Cleared decision on September 11, 2012, 406 days after receiving the submission on August 2, 2011.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660. Elisa For The Detection Of Anti-sla (soluble Liver Antigen) Antibody Of The Igg Class. Intended To Aid In The Diagnosis Of Conditions With Elevated Levels Of Anti-sla Antibody Including Autoimmune Hepatitis.
| 510(k) Number | K112221 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2011 |
| Decision Date | September 11, 2012 |
| Days to Decision | 406 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | NIY — Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |
| Definition | Elisa For The Detection Of Anti-sla (soluble Liver Antigen) Antibody Of The Igg Class. Intended To Aid In The Diagnosis Of Conditions With Elevated Levels Of Anti-sla Antibody Including Autoimmune Hepatitis |