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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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