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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 K092688
Device Name FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Taidoc Technology Corporation
3f,5f, #127 Wugong 2nd Rd.
Wugu Township
Taipei County,  TW 24888
Applicant Contact TELING HSU
Correspondent
Taidoc Technology Corporation
3f,5f, #127 Wugong 2nd Rd.
Wugu Township
Taipei County,  TW 24888
Correspondent Contact TELING HSU
Regulation Number862.1345
Classification Product Code
LFR  
Date Received09/01/2009
Decision Date 07/06/2011
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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