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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 22 Results
ProductCode: GKZ Applicant: SYSMEX AMERICA, INC. Decision Date To: 04/25/2024
 
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sysmex xq-series (xq-320) automated hematology analyzer Sysmex America, Inc. K230887 12/21/2023
sysmex xw-100 automated hematology analyzer Sysmex America, INC. K210346 11/08/2022
counter, differential cell: Sysmex XN-10 Automated Hematology Analyzer Sysmex America, Inc. BK210631 05/23/2022
counter, differential cell: Sysmex XN-10 Automated Hematology Analyzer Sysmex America, Inc. BK210559 05/27/2021
sysmex xn-l automated hematology analyzer Sysmex America, Inc. K182389 01/25/2019
xw-100 automated hematology analyzer for clia waived use Sysmex America, Inc. K172604 11/06/2017
sysmex xn-l automated hematology analyzer SYSMEX AMERICA, INC. K160538 12/22/2016
xw-100 automated hematology analyzer, xw qc check SYSMEX AMERICA, INC. K143577 10/12/2015
sysmex xn series SYSMEX AMERICA, INC. K141681 12/05/2014
sysmex xn-series SYSMEX AMERICA, INC. K112605 10/19/2012
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