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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 BK090079
Tradename Blood Bank Information Management System (BBIMS V2.05.01)
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Duley Hopkins and Associates
1200 mountain creek road
# 215
chattanooga,  TN  37405
Regulation Number864.9165
Classification Product Code
MMH  
Date Received12/17/2009
Decision Date 01/13/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
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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