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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 K094005
Device Name FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
TaiDoc Technology Corporation
6f, 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 Received12/28/2009
Decision Date 05/05/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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