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510(k) K052914

RX IMOLA by Randox Laboratories, Ltd. — Product Code CEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2006
Date Received
October 14, 2005
Clearance Type
Traditional
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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