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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 K092902
Device Name U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC
Original Applicant
TaiDoc Technology Corporation
6f, no. 127, wugong 2nd rd
wugu township
taipei county,  TW 24888
Original Contact debra liang
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received09/21/2009
Decision Date 03/02/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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