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510(k) K131189

UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) by Beckman Coulter, Inc. — Product Code CFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2014
Date Received
April 26, 2013
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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