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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 K101509
Model TD-4279, TD-4272
Device Name U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 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
LFR  
Date Received06/01/2010
Decision Date 06/27/2011
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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