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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 drive
bedford,  MA  01730
Applicant Contact photios makris
Correspondent
MEDICA CORP.
5 oak park drive
bedford,  MA  01730
Correspodent 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
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