FDA 510(k) Applications Submitted by Sysmex America, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K081890 07/02/2008 SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER SYSMEX AMERICA, INC.
K032677 08/29/2003 SYSMEX POCH-100I SYSMEX AMERICA, INC.
K182062 08/01/2018 Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device Sysmex America, Inc.
K172604 08/30/2017 XW-100 Automated Hematology Analyzer for CLIA Waived Use Sysmex America, Inc.
K160541 02/26/2016 Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control SYSMEX AMERICA, INC.
K040073 01/14/2004 SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) SYSMEX AMERICA, INC.
K050589 03/08/2005 RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER SYSMEX AMERICA, INC.
K060656 03/13/2006 SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES SYSMEX AMERICA, INC.
K080887 03/31/2008 SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE SYSMEX AMERICA, INC.
K061150 04/25/2006 SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES SYSMEX AMERICA, INC.
K051459 06/02/2005 SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER SYSMEX AMERICA, INC.
K081610 06/09/2008 SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER SYSMEX AMERICA, INC.
K083002 10/08/2008 SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER SYSMEX AMERICA, INC.
K053135 11/08/2005 SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER SYSMEX AMERICA, INC.
K070910 04/02/2007 SYSMEX MODEL UF1000I SYSMEX AMERICA, INC.
K051199 05/10/2005 IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER SYSMEX AMERICA, INC.
K032039 07/01/2003 IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER SYSMEX AMERICA, INC.
K071967 07/16/2007 SYSMEX XE-5000 SYSMEX AMERICA, INC.
K143577 12/17/2014 XW-100 Automated Hematology Analyzer, XW QC CHECK SYSMEX AMERICA, INC.
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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