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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 K113077
Model MODEL G-423
Device Name BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
TAIDOC TECHNOLOGY CORPORATION
3f, 5f, no 127 wugong 2nd rd
wugu township, wugu dist
new taipei city,  TW 24888
Original Contact linda ko
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received10/17/2011
Decision Date 08/03/2012
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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