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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name counter, differential cell
510(k) Number BK210559
Tradename Sysmex XN-10 Automated Hematology Analyzer
Device Name Counter, Differential Cell
Original Applicant
Sysmex America, Inc.
577 aptakisic rd
lincolnshire,  IL  60069
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received03/04/2021
Decision Date 05/27/2021
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 Yes
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