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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 K120183
Device Name ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Broadmaster Biotech Corperation
7f, # 168-2, Liancheng Rd.
Zhonghe Dist,  TW 23553
Applicant Contact ROGER LAI
Correspondent
Broadmaster Biotech Corperation
7f, # 168-2, Liancheng Rd.
Zhonghe Dist,  TW 23553
Correspondent Contact ROGER LAI
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received01/23/2012
Decision Date 05/11/2012
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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