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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name glucose dehydrogenase, glucose
510(K) Number K120042
Model TD-4268
Device Name TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM
Applicant
TAIDOC TECHNOLOGY CORPORATION
3f,5f, no.127, wugong 2nd rd.
wugu district
new taipei city, 
Contact meiru li
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Code
NBW  
Date Received01/05/2012
Decision Date 05/22/2012
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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