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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 K061181
Device Name ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207
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 Code
CGA  
Date Received04/27/2006
Decision Date 07/06/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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