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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 K162382
Device Name Smart Dongle Blood Glucose Monitoring System
Applicant
TaiDoc Technology Corporation
B1-7F, No. 127, Wugong 2nd Rd.,
Wugu District
new taipei city,  TW 24888
Applicant Contact paul liu
Correspondent
TaiDoc Technology Corporation
B1-7F, No. 127, Wugong 2nd Rd.,
Wugu District
new taipei city,  TW 24888
Correspondent Contact paul liu
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JQP   LFR  
Date Received08/24/2016
Decision Date 04/14/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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