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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 K041107
Device Name TAIDOC CHECK
Applicant
Taidoc Technology Corporation
4f,#88,Sec. 1,Kwang-Fu Rd.,
San-Chung
Taipei,County,  TW 241
Applicant Contact SHU-MEI WU
Correspondent
Taidoc Technology Corporation
4f,#88,Sec. 1,Kwang-Fu Rd.,
San-Chung
Taipei,County,  TW 241
Correspondent Contact SHU-MEI WU
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received04/28/2004
Decision Date 06/18/2004
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
Predetermined Change
Control Plan Authorized		 No
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