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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name glucose dehydrogenase, glucose
510(k) Number K121207
Model MU12001, MU12007
Device Name EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
Original Applicant
EPS BIO TECHNOLOGY CORP.
no.8 r&d rd iii
hsinchu science park
hsinchu city,,  TW 30077
Original Contact cynthia hung
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Codes
JJX   NBW  
Date Received04/20/2012
Decision Date 05/18/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
statement statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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