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. |
| K250965 |
03/31/2025 |
Automated Blood Coagulation Analyzer CN-Series (CN-6000) |
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. |
| K250943 |
03/28/2025 |
Sysmex XR-Series (XR-10) Automated Hematology Analyzer |
Sysmex America, Inc. |
| K230887 |
03/31/2023 |
Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer |
Sysmex America, Inc. |
| K251371 |
05/02/2025 |
Sysmex XR-Series (XR-20) Automated Hematology Analyzer |
Sysmex America, Inc. |
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