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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 K101631
Model TD-4251, TD-4252
Device Name FORA G20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
TAIDOC TECHNOLOGY CORPORATION
3f, 5f, no 127 wugong 2nd rd
wugu township
taipei county,  TW 24888
Original Contact teling hsu
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   LFR  
Date Received06/10/2010
Decision Date 09/02/2011
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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