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510(k) K041002

FIDIS CELIAC by Biomedical Diagnostics S.A. — Product Code MST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2004
Date Received
April 19, 2004
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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