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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 K102049
Model TD-4248
Device Name CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
TAIDOC TECHNOLOGY CORPORATION
3f,5f, no.127 wugong 2nd rd,
wugu township
taipei county,  TW 24888
Original Contact teling hsu
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received07/21/2010
Decision Date 05/27/2011
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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