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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 K093635
Model FORA V30 & TD-4242
Device Name MODELS FORA V30 AND TD-4242 BLOOD GLUCOSE MONITORING SYSTEMS
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 Received11/23/2009
Decision Date 02/18/2010
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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