Sysmex America, Inc.
FDA 510(k) & PMA Approved Devices — 11 products
Total Devices11
Categories5
Latest Approval2025-06-25
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | GKZ | 2025-06-25 | View |
| 510(k) | K251371 | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | GKZ | 2025-06-25 | View |
| 510(k) | K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000) | JPA | 2025-06-02 | View |
| 510(k) | K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer | GKZ | 2023-12-21 | View |
| 510(k) | K210346 | Sysmex XW-100 Automated Hematology Analyzer | GKZ | 2022-11-08 | View |
| 510(k) | K182389 | Sysmex XN-L Automated Hematology Analyzer | GKZ | 2019-01-25 | View |
| 510(k) | K182062 | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device | JOY | 2018-10-30 | View |
| 510(k) | K171883 | Sysmex UF-5000 Fully Automated Urine Particle Analyzer | LKM | 2018-04-23 | View |
| 510(k) | K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived Use | GKZ | 2017-11-06 | View |
| 510(k) | K160538 | Sysmex XN-L Automated Hematology Analyzer | GKZ | 2016-12-22 | View |
| 510(k) | K160541 | Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control | JLW | 2016-10-21 | View |
No matching devices.