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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name separator, automated, blood cell, diagnostic
510(k) Number BK251292
Tradename NexSys PCS Plasma Collection System with Persona Plus Technology
Device Name Automated Blood Cell Separators
Original Applicant
Haemonetics Corporation
125 summer st
boston,  MA  02110
Regulation Number864.9245
Classification Product Code
GKT  
Date Received11/12/2025
Decision Date 02/20/2026
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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