FDA 510(k)

Sysmex XN-L 自动血液分析仪

K号: K182389 · 2019-01-25

决定日期2019-01-25

产品代码GKZ

咨询委员会HE 请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Sysmex XN-L 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 2019-01-25 under 510(k) number K182389. 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 Sysmex XN-L Automated Hematology Analyzer?

Sysmex XN-L Automated Hematology Analyzer is a medical device that received FDA 510(k) clearance on 2019-01-25. The listed applicant is Sysmex America, Inc.. The 510(k) number is K182389.

When did Sysmex XN-L Automated Hematology Analyzer receive FDA 510(k) clearance?

Sysmex XN-L Automated Hematology Analyzer received FDA 510(k) clearance on 2019-01-25, under 510(k) number K182389.

Who is the listed applicant for Sysmex XN-L 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 XN-L Automated Hematology Analyzer?

The FDA product code for Sysmex XN-L Automated Hematology Analyzer 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。

K253212XR系列（XR-10，XR-20）自动血液分析仪 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

查看所有 12 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。