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Sysmex America, Inc.

FDA 510(k) & PMA Approved Devices — 29 products

Total Devices29
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K253212 XR-Series (XR-10, XR-20) Automated Hematology AnalyzersGKZ2026-05-27 View
510(k) K251371 Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ2025-06-25 View
510(k) K250943 Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ2025-06-25 View
510(k) K250965 Automated Blood Coagulation Analyzer CN-Series (CN-6000)JPA2025-06-02 View
510(k) K230887 Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerGKZ2023-12-21 View
510(k) K210346 Sysmex XW-100 Automated Hematology AnalyzerGKZ2022-11-08 View
510(k) K182389 Sysmex XN-L Automated Hematology AnalyzerGKZ2019-01-25 View
510(k) K182062 Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceJOY2018-10-30 View
510(k) K171883 Sysmex UF-5000 Fully Automated Urine Particle AnalyzerLKM2018-04-23 View
510(k) K172604 XW-100 Automated Hematology Analyzer for CLIA Waived UseGKZ2017-11-06 View
510(k) K160538 Sysmex XN-L Automated Hematology AnalyzerGKZ2016-12-22 View
510(k) K160541 Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi ControlJLW2016-10-21 View
510(k) K112605 SYSMEX XN-SERIESGKZ2012-10-19 View
510(k) K091313 SYSMEX MODEL XT-4000IGKZ2010-03-30 View
510(k) K083002 SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZERLKM2009-02-03 View
510(k) K081890 SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETERGKZ2008-10-10 View
510(k) K081610 SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZERGKZ2008-08-29 View
510(k) K080887 SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARELKM2008-05-02 View
510(k) K071967 SYSMEX XE-5000GKZ2007-11-20 View
510(k) K070910 SYSMEX MODEL UF1000ILKM2007-05-25 View
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