FDA 510(k) Applications Submitted by Sharita Brooks

FDA 510(k) Number Submission Date Device Name Applicant
K210346 02/08/2021 Sysmex XW-100 Automated Hematology Analyzer Sysmex America, INC.
K160538 02/26/2016 Sysmex XN-L Automated Hematology Analyzer SYSMEX AMERICA, INC.
K091313 05/04/2009 SYSMEX MODEL XT-4000I SYSMEX AMERICA, INC.
K141681 06/23/2014 SYSMEX XN SERIES SYSMEX AMERICA, INC.
K171883 06/23/2017 Sysmex UF-5000 Fully Automated Urine Particle Analyzer Sysmex America, Inc.
K182389 09/04/2018 Sysmex XN-L Automated Hematology Analyzer Sysmex America, Inc.
K112605 09/07/2011 SYSMEX XN-SERIES SYSMEX AMERICA, INC.


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