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510(k) K033744

AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA by Hycor Biomedical , Ltd. — Product Code MVM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2004
Date Received
December 1, 2003
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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