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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Dehydrogenase, Glucose
510(k) Number K113768
Device Name U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM
Applicant
TaiDoc Technology Corporation
6F, NO. 127, WUGONG 2ND RD
WUGU TOWNSHIP
NEW TAIPEI CITY,  TW 248
Applicant Contact MEIRU LI
Correspondent
TaiDoc Technology Corporation
6F, NO. 127, WUGONG 2ND RD
WUGU TOWNSHIP
NEW TAIPEI CITY,  TW 248
Correspondent Contact MEIRU LI
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Code
NBW  
Date Received12/21/2011
Decision Date 04/12/2012
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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