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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 K093035
Model TD-4244
Device Name FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244
Original Applicant
TAIDOC TECHNOLOGY CORPORATION
6f, no. 127, wugong 2nd rd
wugu township
taipei county,  TW 248
Original Contact debra lang
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received09/30/2009
Decision Date 12/24/2009
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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