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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Albumin, Antigen, Antiserum, Control
510(k) Number K101089
Device Name EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
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 Number866.5040
Classification Product Code
DCF  
Subsequent Product Code
JIT  
Date Received04/19/2010
Decision Date 07/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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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