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510(k) K230890

ISE Electrodes by Randox Laboratories, Ltd. — Product Code CEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2023
Date Received
March 31, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Potassium
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type

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