510(k) K100673

EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020 by Medica Corp. — Product Code JGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2010
Date Received
March 9, 2010
Clearance Type
Special
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