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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 K112963
Model TD-4257,TD-4257
Device Name TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE MONITORING SYSTEMS
Original Applicant
TAIDOC TECHNOLOGY CORPORATION
3f,5f, no.127, wugong 2nd rd.
wugu district
new taipei city,  TW 24888
Original Contact teling hsu
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received10/05/2011
Decision Date 11/22/2011
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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