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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 BK960044
Tradename Blood Bank Control System
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Blood Bank Computer Systems, Inc.
1501 west valley highway, north
suite 101
auburn,  WA  98001
Regulation Number864.9165
Classification Product Code
MMH  
Date Received03/29/1996
Decision Date 10/15/1997
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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