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510(k) K153644

ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II by Elitechgroup — Product Code CFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2016
Date Received
December 21, 2015
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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