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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 K062800
Device Name CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER CHEK TD-3217/ CLEVER CHEK TD-3250 BLOOD GLUCOSE PLUS BLO
Original Applicant
TAIDOC TECHNOLOGY CORPORATION
4f, 88, sec.1, kwang fu road
san chung, taipei,  TW 241
Original Contact pi-shiou li
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   DXN  
Date Received09/19/2006
Decision Date 01/12/2007
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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