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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, Calcium
510(k) Number K943091
Device Name EASY LYTE CALCIUM ANALYZER
Applicant
Medica Corp.
14 Deangelo Dr.
Bedford,  MA  01730
Applicant Contact PHOTIOS MAKRIS, PH.D.
Correspondent
Medica Corp.
14 Deangelo Dr.
Bedford,  MA  01730
Correspondent Contact PHOTIOS MAKRIS, PH.D.
Regulation Number862.1145
Classification Product Code
JFP  
Subsequent Product Codes
CEM   CHL   JGS  
Date Received06/28/1994
Decision Date 01/17/1995
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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