FDA.report

510(k) K251371

Device
Sysmex XR-Series (XR-20) Automated Hematology Analyzer
Applicant
Sysmex America, Inc.
510(k) number
K251371
Product code
GKZ
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-25
Date received
2025-05-02
Regulation
864.5220
Classification name
Counter, Differential Cell
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Yvonne Doswell
Address
577 Aptakisic Rd. Lincolnshire IL US 60069 60069

FDA Registration Numbers

Source Documents

510(k) summary PDF

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