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510(k) K160402

GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) by Instrumentation Laboratory CO — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2016
Date Received
February 12, 2016
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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