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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 K112275
Device Name FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM
Applicant
TaiDoc Technology Corporation
3F,5F, NO.127 WUGONG 2ND RD,
WUGU DISTRICT
NEW TAIPEI CITY,  TW 24888
Applicant Contact LINDA KO
Correspondent
TaiDoc Technology Corporation
3F,5F, NO.127 WUGONG 2ND RD,
WUGU DISTRICT
NEW TAIPEI CITY,  TW 24888
Correspondent Contact LINDA KO
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received08/08/2011
Decision Date 12/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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