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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK051854/A003
Test Name BTNX Inc. Rapid Response Blood Glucose Monitoring System  
Manufacturer NameTaidoc Technology Corporation
Consumer Information Phone Number(888)339-9964
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date04/12/2007
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K051854
Device Name CLEVER CHEK TD-4225, MODEL TD-4225
Applicant
Taidoc Technology Corporation
4f, 88, Sec. 1, Kwang Fu Rd.
San Chung, Taipei,  TW 241
Applicant Contact SHU-MEI WU
Correspondent
Taidoc Technology Corporation
4f, 88, Sec. 1, Kwang Fu Rd.
San Chung, Taipei,  TW 241
Correspondent Contact SHU-MEI WU
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received07/08/2005
Decision Date 08/05/2005
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
Predetermined Change
Control Plan Authorized		 No
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