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FDA 510(k)

Sysmex XR-Series (XR-20) Automated Hematology Analyzer

K-Number: K251371 · 2025-06-25

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

Device Summary

Sysmex XR-Series (XR-20) Automated Hematology Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Sysmex America, Inc.. It received FDA 510(k) clearance on 2025-06-25 under 510(k) number K251371. 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-20) Automated Hematology Analyzer?

Sysmex XR-Series (XR-20) Automated Hematology Analyzer is a medical device that received FDA 510(k) clearance on 2025-06-25. The listed applicant is Sysmex America, Inc.. The 510(k) number is K251371.

When did Sysmex XR-Series (XR-20) Automated Hematology Analyzer receive FDA 510(k) clearance?

Sysmex XR-Series (XR-20) Automated Hematology Analyzer received FDA 510(k) clearance on 2025-06-25, under 510(k) number K251371.

Who is the listed applicant for Sysmex XR-Series (XR-20) Automated Hematology Analyzer?

The FDA 510(k) record lists Sysmex America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sysmex XR-Series (XR-20) Automated Hematology Analyzer?

The FDA product code for Sysmex XR-Series (XR-20) Automated Hematology Analyzer is GKZ.

Other records listing Sysmex America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersK250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerK250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)K230887Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerK210346Sysmex XW-100 Automated Hematology AnalyzerK182389Sysmex XN-L Automated Hematology Analyzer

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Related Devices (Code: GKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K243283Alinity h-series SystemAbbott LaboratoriesK240402Cito CBC SystemCytochip, Inc.

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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