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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 K063212
Device Name CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM
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 Received10/23/2006
Decision Date 11/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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