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Sysmex America, Inc.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories5
Latest FDA decision2026-05-27
TypeNumberDevice NameCodeDateActions
510(k) K253212 XR-Series (XR-10, XR-20) Automated Hematology AnalyzersGKZ2026-05-27 View
510(k) K250943 Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ2025-06-25 View
510(k) K251371 Sysmex XR-Series (XR-20) 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
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