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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K120497
Device Name EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL
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 Number864.7470
Classification Product Code
LCP  
Subsequent Product Codes
JIT   JJX  
Date Received02/21/2012
Decision Date 05/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
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
Recalls CDRH Recalls
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