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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, Chloride
510(k) Number K000926
Device Name EASYELECTROLYTE ANALYZER AND RAPIDLYTE 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 Number862.1170
Classification Product Code
CGZ  
Subsequent Product Codes
CEM   JGS  
Date Received03/22/2000
Decision Date 05/15/2000
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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