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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 K141944
Device Name HOME ACCESS AIC TEST
Applicant
HOME ACCESS HEALTH CORP.
62 FOREST STREET SUITE 300
MARLBOROUGH,  MA  01752
Applicant Contact Sandra D White
Correspondent
ICON Clinical Research LLC
62 FOREST STREET SUITE 300
MARLBOROUGH,  MA  01752
Correspondent Contact Sandra D White
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
JKA  
Date Received07/17/2014
Decision Date 03/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT01913145
Reviewed by Third Party No
Combination Product No
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