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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
Device Name GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM
Applicant
TaiDoc Technology Corporation
3F,5F, No.127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Applicant Contact LINDA KO
Correspondent
TaiDoc Technology Corporation
3F,5F, No.127, Wugong 2nd Rd.
Wugu District
New Taipei City,  TW 24888
Correspondent Contact LINDA KO
Regulation Number862.1345
Classification Product Code
LFR  
Subsequent Product Codes
JJX   NBW  
Date Received04/20/2012
Decision Date 09/19/2012
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
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