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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, Potassium
510(k) Number K961326
Device Name EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER
Applicant
Medica Corp.
14 Deangelo Dr.
Bedford,  MA  01730
Applicant Contact Photios Makris
Correspondent
Medica Corp.
14 Deangelo Dr.
Bedford,  MA  01730
Correspondent Contact Photios Makris
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
JGS   JIH  
Date Received04/08/1996
Decision Date 06/21/1996
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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