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FDA 510(k)

Sysmex XR-Series (XR-10) Automated Hematology Analyzer

K-Number: K250943 · 2025-06-25

ApplicantSysmex America, Inc.
Decision Date2025-06-25
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Sysmex XR-Series (XR-10) Automated Hematology Analyzer is a medical device manufactured by Sysmex America, Inc.. It received FDA 510(k) clearance on 2025-06-25 under approval number K250943. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sysmex XR-Series (XR-10) Automated Hematology Analyzer?

Sysmex XR-Series (XR-10) Automated Hematology Analyzer is a medical device that received FDA 510(k) clearance on 2025-06-25. It is manufactured by Sysmex America, Inc.. The 510(k) number is K250943.

When was Sysmex XR-Series (XR-10) Automated Hematology Analyzer approved by the FDA?

Sysmex XR-Series (XR-10) Automated Hematology Analyzer received FDA 510(k) clearance on 2025-06-25, under approval number K250943.

What company makes Sysmex XR-Series (XR-10) Automated Hematology Analyzer?

Sysmex XR-Series (XR-10) Automated Hematology Analyzer is manufactured by Sysmex America, Inc..

What is the FDA product code for Sysmex XR-Series (XR-10) Automated Hematology Analyzer?

The FDA product code for Sysmex XR-Series (XR-10) Automated Hematology Analyzer is GKZ.

Other Devices by Sysmex America, Inc.

K160538Sysmex XN-L Automated Hematology Analyzer K160541Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control K172604XW-100 Automated Hematology Analyzer for CLIA Waived Use K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device K171883Sysmex UF-5000 Fully Automated Urine Particle Analyzer K182389Sysmex XN-L Automated Hematology Analyzer

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Related Devices (Code: GKZ)

K160538Sysmex XN-L Automated Hematology AnalyzerSysmex America, Inc. K162414UniCel DxH SlideMaker Stainer Coulter Cellular Analysis SystemBeckman Coulter, Inc. K160429BC-5390 Auto Hematology AnalyzerMindray Bio-Medical Electronics Co., Ltd. K172604XW-100 Automated Hematology Analyzer for CLIA Waived UseSysmex America, Inc. K170353ABX MICROS ES 60 OT and ABX MICROS ES 60 CTHORIBA ABX SAS K162977ADVIA 2120i, ADVIA 2120Siemens Healthcare Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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