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510(k) K043433

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2005
Date Received
December 13, 2004
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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