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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, detection, bacterial, for platelet transfusion products
510(k) Number BK080014
Tradename Pall eBDS
Device Name System, Detection, Bacterial, Detection Systems for Platelet Transfusion Products
Original Applicant
Pall Corporation
25 harbor park drive
port washington,  NY  11050 4630
Regulation Number866.2560
Classification Product Code
MZC  
Date Received03/25/2008
Decision Date 02/13/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Immunology
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 Yes
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