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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name blood establishment computer software and accessories
510(k) Number BK100037
Tradename RC-AID
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
BBK Technology LLC
2910 e highland ave
phoenix,  AZ  85016
Regulation Number864.9165
Classification Product Code
MMH  
Date Received06/09/2010
Decision Date 09/13/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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