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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 K121224
Model TD-4123
Device Name GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
TAIDOC TECHNOLOGY CORPORATION
3f,5f, no.127, wugong 2nd rd.
wugu district
new taipei city,  TW 24888
Original Contact linda ko
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Codes
JJX   NBW  
Date Received05/09/2012
Decision Date 09/19/2012
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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