510(k) K112221
K112221 is an FDA 510(k) premarket notification submitted by Euroimmun US for the device "EUROIMMUN ANTI-SLA/LP ELISA(LGG)". The FDA issued a decision of Substantially Equivalent on September 11, 2012. The device falls under product code NIY (Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis), a Class II device regulated under 21 CFR 866.5660. Euroimmun US has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2012
- Date Received
- August 2, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
- Device Class
- Class II
- Regulation Number
- 866.5660
- Review Panel
- IM
- Submission Type
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