FDA 510(k)

XR系列（XR-10，XR-20）自动血液分析仪

K号: K253212 · 2026-05-27

决定日期2026-05-27

产品代码GKZ

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决定实质等同

器械摘要

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.

常见问题

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.

列明Sysmex America, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250943Sysmex XR-Series (XR-10) 自动血液分析仪 K251371Sysmex XR-Series (XR-20) 自动血液分析仪 K250965自动血凝分析仪CN系列（CN-6000）K230887Sysmex XQ-Series (XQ-320) 自动血液分析仪 K210346Sysmex XW-100 自动血液分析仪 K182389Sysmex XN-L 自动血液分析仪

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官方来源

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