Sysmex Corporation of America
United StatesFDA applicant, unverified
- Devices
- 3
What Sysmex Corporation of America makes
Sysmex Corporation of America manufactures automated hematology analyzers, including the SYSMEX R-500 for routine blood cell counting and the SYSMEX XT-series (XT-2000I, XT-1800I) for specialized blood analysis. Their portfolio also includes the HPC parameter on the IMI channel of the SE-9500 and XE-2100 systems, designed for measuring hematopoietic progenitor cells in blood samples.
These devices are classified as Class II under FDA regulations and are recorded in the 510(k) clearance database. The company is headquartered in the United States.
Catalogue
Sysmex R-500 Ref K001683
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Sysmex Xt-Series, Model Xt-2000I And Xt-1800I Ref K021241
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sysmex Corporation of America have in the registry?
The registry currently lists 3 devices for Sysmex Corporation of America. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sysmex Corporation of America's devices?
Among its 3 most recently registered devices, Sysmex Corporation of America has devices listed in FDA 510(k) (3 devices).
What risk classes do Sysmex Corporation of America's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Sysmex Corporation of America's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sysmex Corporation of America in the registry?
The most recently registered devices listed for Sysmex Corporation of America include SYSMEX R-500, HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY and SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I.