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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, test, blood glucose, over the counter
510(k) Number K113192
Model IGM-0028A, IGM-0028B
Device Name HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
INFOPIA CO., LTD
951 starbuck st. unit j
fullerton,  CA  92833
Original Contact priscilla chung
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received10/31/2011
Decision Date 07/13/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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