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510(k) K121140

PROLYTE ELECTROLYTE ANALYZER by Diamond Diagnostics, Inc. — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2012
Date Received
April 16, 2012
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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