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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 BK960040
Tradename NBCS 1.1
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
American Red Cross
diagnostic manufacturing division
2025 e street nw
washington,  DC  20006
Regulation Number864.9165
Classification Product Code
MMH  
Date Received04/01/1996
Decision Date 02/28/1997
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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