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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Sodium
510(k) Number K864872
Device Name MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER
Applicant
Medica Corp.
14 Deangelo Dr.
Bedford,  MA  01730
Applicant Contact ROBERT W HAGOPIAN
Correspondent
Medica Corp.
14 Deangelo Dr.
Bedford,  MA  01730
Correspondent Contact ROBERT W HAGOPIAN
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Code
CEM  
Date Received12/12/1986
Decision Date 03/13/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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