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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 BK110055
Tradename MediCopia Transfusion
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Lattice, Inc.
1751 south naperville rd
suite 100
wheaton,  IL  60189
Regulation Number864.9165
Classification Product Code
MMH  
Date Received09/13/2011
Decision Date 01/06/2012
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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