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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 K201037
Device Name FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
Applicant
Taidoc Technology Corporation
6f, #127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Applicant Contact Jacky Chou
Correspondent
Taidoc Technology Corporation
B1-7f, #127, Wugong 2nd Rd.
New Taipei City,  TW 24888
Correspondent Contact Jacky Chou
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CHH   JIN  
Date Received04/20/2020
Decision Date 06/16/2022
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
Predetermined Change
Control Plan Authorized		 No
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