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510(k) K121040

SMARTLYTE ELECTROLYTE ANALYZER by Diamond Diagnostics, Inc. — Product Code CEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2012
Date Received
April 5, 2012
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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