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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
Models BMB-EA001S, BMB-EA002A, BMB-EA002B, BMB-EA004A, BMB-EA004S
Device Name ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM
Original Applicant
BROADMASTER BIOTECH CORPERATION
7f, no. 168-2, liancheng rd.
zhonghe dist,  TW 23553
Original 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 - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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