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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 BK100069
Tradename LifeTrak/Plasma
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
MEDIWARE INFORMATION SYSTEMS, INC.
11711 west 79th street
lenexa,  KS  66214
Regulation Number864.9165
Classification Product Code
MMH  
Date Received12/20/2010
Decision Date 03/04/2011
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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