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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 BK050018
Tradename Centricity Ultra Laboratory Transfusion Medicine (Ultra TM)
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
GE Medical Information Technologies
540 northwest highway
barrington,  IL  60010
Regulation Number864.9165
Classification Product Code
MMH  
Date Received03/23/2005
Decision Date 06/13/2005
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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