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510(k) K101741

DIATRON PICTUS 400 by Diatron Group — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2011
Date Received
June 22, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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