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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 K042005
Device Name ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222
Original Applicant
TAIDOC TECHNOLOGY CORPORATION
4f, 88, sec.1, kwang fu road
san chung, taipei,  TW 241
Original Contact shu-mei wu
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received07/26/2004
Decision Date 08/27/2004
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
statement statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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