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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 K123802
Device Name EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK 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 Code
CGS  
Date Received12/10/2012
Decision Date 03/01/2013
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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