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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 K071493
Device Name CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225
Applicant
Taidoc Technology Corporation
4f, 88, Sec.1, Kwang Fu Rd.
San Chung,Taipei County R.O.C.
San Chung, Taipei,  TW 241
Applicant Contact ERICA LI
Correspondent
Taidoc Technology Corporation
4f, 88, Sec.1, Kwang Fu Rd.
San Chung,Taipei County R.O.C.
San Chung, Taipei,  TW 241
Correspondent Contact ERICA LI
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received05/30/2007
Decision Date 10/26/2007
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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