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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 K092099
Model TD-4251, TD-4252, TD-4253 AND TD-4254
Device Name NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254
Original Applicant
TAIDOC TECHNOLOGY CORPORATION
6f, no. 127, wugong 2nd rd
wugu township
taipei county,  TW 248
Original Contact debra liang
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received07/14/2009
Decision Date 12/10/2009
Decision substantially equivalent (SE)
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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