510(k) K152327

EasyLyte Na/K/Cl/Ca Analyzer by Medica Corporation — Product Code JFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2016
Date Received
August 18, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type