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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 K082618
Device Name ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455
Original Applicant
TAIDOC TECHNOLOGY CORPORATION
6f, no. 127, wugong 2nd rd
wugu township
taipei county,  TW 241
Original Contact yuhua chen
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received09/09/2008
Decision Date 10/07/2008
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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