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510(k) K183313

EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) by Euroimmun Us, Inc. — Product Code MVM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2019
Date Received
November 29, 2018
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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