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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 BK040065
Tradename Misys Laboratory Blood Bank and Blood Donor
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Misys Healthcare Systems
4801 east broadway boulevard
tucson,  AZ  85711
Regulation Number864.9165
Classification Product Code
MMH  
Date Received08/13/2004
Decision Date 10/22/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Abbreviated
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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