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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K072249
Device Name EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT
Applicant
Medica Corp.
163 Cabot St.
Beverly,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
Medica Corp.
163 Cabot St.
Beverly,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number862.1175
Classification Product Code
CHH  
Subsequent Product Code
CJY  
Date Received08/13/2007
Decision Date 02/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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