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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 K092875
Model TD-3227
Device Name ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER
Original Applicant
TAIDOC TECHNOLOGY CORPORATION
6f, no. 127, wugong 2nd rd
wugu township
taipei county,  TW 24888
Original Contact debra liang
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   DXN  
Date Received09/18/2009
Decision Date 08/13/2010
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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