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510(k) K161837

ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer by Beckman Coulter, Inc. — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2016
Date Received
July 5, 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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