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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK101509
Test Name Fora Care Inc., U-Right TD-4279A/B Blood Glucose Monitoring System  
Manufacturer NameTaiDoc Technology Corporation
Consumer Information Phone Number(866)469-2632
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date06/29/2011
Device Classification Name system, test, blood glucose, over the counter
510(k) Number K101509
Device Name U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM
Applicant
TaiDoc Technology Corporation
3F,5F, NO.127 WUGONG 2ND RD,
WUGU TOWNSHIP
TAIPEI COUNTY,  TW 24888
Applicant Contact TELING HSU
Correspondent
TaiDoc Technology Corporation
3F,5F, NO.127 WUGONG 2ND RD,
WUGU TOWNSHIP
TAIPEI COUNTY,  TW 24888
Correspondent Contact TELING HSU
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received06/01/2010
Decision Date 06/27/2011
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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