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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 K102316
Device Name GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Broadmaster Biotech Corporation
7f, # 168-2, Liancheng
Zhonghe City,  TW 23553
Applicant Contact ROGER LAI
Correspondent
Broadmaster Biotech Corporation
7f, # 168-2, Liancheng
Zhonghe City,  TW 23553
Correspondent Contact ROGER LAI
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
JJX   NBW  
Date Received08/16/2010
Decision Date 10/07/2011
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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