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510(k) K160225

GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator by Instrumentation Laboratory CO — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2016
Date Received
January 29, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type

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