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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name blood establishment computer software and accessories
510(k) Number BK950064
Tradename Lifeline Blood Bank Data Management System, Release 4.2
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Informatics
4000 kruso way place
building 3 suite 210
lake oswego,  OR  97035
Regulation Number864.9165
Classification Product Code
MMH  
Date Received10/31/1995
Decision Date 07/01/1998
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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