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510(k) K220977

ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2023
Date Received
April 4, 2022
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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