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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 BK950053
Tradename Pathnet Blood Bank Transfusion (L-2300)
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Cerner Corporation
2800 rock creek parkway
kansas city,  MO  64117 2551
Regulation Number864.9165
Classification Product Code
MMH  
Date Received10/03/1995
Decision Date 07/16/1997
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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