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FDA 510(k)

XR-Series (XR-10, XR-20) Automated Hematology Analyzers

K-Number: K253212 · 2026-05-27

ApplicantSysmex America, Inc.
Decision Date2026-05-27
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

XR-Series (XR-10, XR-20) Automated Hematology Analyzers 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 2026-05-27 under 510(k) number K253212. 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 XR-Series (XR-10, XR-20) Automated Hematology Analyzers?

XR-Series (XR-10, XR-20) Automated Hematology Analyzers is a medical device that received FDA 510(k) clearance on 2026-05-27. The listed applicant is Sysmex America, Inc.. The 510(k) number is K253212.

When did XR-Series (XR-10, XR-20) Automated Hematology Analyzers receive FDA 510(k) clearance?

XR-Series (XR-10, XR-20) Automated Hematology Analyzers received FDA 510(k) clearance on 2026-05-27, under 510(k) number K253212.

Who is the listed applicant for XR-Series (XR-10, XR-20) Automated Hematology Analyzers?

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 XR-Series (XR-10, XR-20) Automated Hematology Analyzers?

The FDA product code for XR-Series (XR-10, XR-20) Automated Hematology Analyzers 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.

K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerK250943Sysmex 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

View all 12 devices →

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.

K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, 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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