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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K080810
Device Name EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT
Applicant
Medica Corp.
5 Oak Park Dr.
Bedford,  MA  01730
Applicant Contact Photios Makris
Correspondent
Medica Corp.
5 Oak Park Dr.
Bedford,  MA  01730
Correspondent Contact Photios Makris
Regulation Number862.1110
Classification Product Code
CIG  
Subsequent Product Codes
CEO   JGJ   JIY  
Date Received03/21/2008
Decision Date 12/10/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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