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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 K151100
Device Name U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System
Applicant
Taidoc Technology Corporation
B1-7f, #127, Wugong 2nd Rd.
New Taipei City,  TW 24888
Applicant Contact C.W. CHEN
Correspondent
Taidoc Technology Corporation
B1-7f, #127, Wugong 2nd Rd.
New Taipei City,  TW 24888
Correspondent Contact PAUL LIU
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received04/24/2015
Decision Date 09/29/2015
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
Predetermined Change
Control Plan Authorized		 No
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