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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K100405
Device Name FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Taidoc Technology Corporation
3f,5f, #127 Wugong 2nd Rd.
Wugu Township
Taipei County,  TW 24888
Applicant Contact NICKY PAN
Correspondent
Taidoc Technology Corporation
3f,5f, #127 Wugong 2nd Rd.
Wugu Township
Taipei County,  TW 24888
Correspondent Contact NICKY PAN
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received02/16/2010
Decision Date 07/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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