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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK062235/A002
Test Name Vertex Diagnostics UltraTRAK Blood Glucose Monitoring System  
Manufacturer NameTaiDoc Technology Corporation
Consumer Information Phone Number1(866)585-1392
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date11/16/2007
Device Classification Name system, test, blood glucose, over the counter
510(k) Number K062235
Device Name EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST
Applicant
TaiDoc Technology Corporation
4F, 88, SEC.1, KWANG FU ROAD
SAN CHUNG, TAIPEI,  TW 241
Applicant Contact PI-SHIOU LI
Correspondent
TaiDoc Technology Corporation
4F, 88, SEC.1, KWANG FU ROAD
SAN CHUNG, TAIPEI,  TW 241
Correspondent Contact PI-SHIOU LI
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received08/02/2006
Decision Date 09/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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