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510(k) K103788

PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT by HORIBA ABX SAS — Product Code CFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2011
Date Received
December 27, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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