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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name glucose oxidase, glucose
510(k) Number K113670
Device Name ELEMENT 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
CGA  
Subsequent Product Codes
JJX   NBW  
Date Received12/13/2011
Decision Date 05/08/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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