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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 BK150347
Tradename Lookback Notification System (LNS), Version 1.0
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
BioLife Plasma Services L.P. - Baxalta US Inc
440 n. fairway drive, 2w - 141
vernon hills,  IL  60061
Regulation Number864.9165
Classification Product Code
MMH  
Date Received11/24/2015
Decision Date 02/12/2016
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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