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510(k) K112221

EUROIMMUN ANTI-SLA/LP ELISA(LGG) by Euroimmun US — Product Code NIY

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

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