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510(k) K091520

IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA by Immco Diagnostics, Inc. — Product Code MVM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2010
Date Received
May 22, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Autoantibodies, Endomysial(Tissue Transglutaminase)
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

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