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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 K100732
Model TD-4241
Device Name FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
Original Applicant
TAIDOC TECHNOLOGY CORPORATION
3f, 5f, no 127 wugong 2nd rd
wugu township
taipei county,  TW 248
Original Contact nicky pan
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received03/15/2010
Decision Date 07/09/2010
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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