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510(k) K083053

EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) by Euroimmun Us, Inc. — Product Code MST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2009
Date Received
October 14, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antibodies, Gliadin
Device Class
Class II
Regulation Number
866.5750
Review Panel
IM
Submission Type

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