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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name centrifuge, cell-washing, automated for immuno-hematology
510(k) Number BK160044
Tradename Thermo Scientific CW3 Cell Washer
Device Name Centrifuge, Cell-Washing, Automated for Immunohematology
Original Applicant
Thermo Electron LED GmbH (a subsidiary of Thermo Fisher Scientific Inc.)
am kalkberg
osterode am harz,  Germany,  37520, 
Regulation Number864.9285
Classification Product Code
KSN  
Date Received05/17/2016
Decision Date 10/07/2016
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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