FDA 510(k)

Alinity h系列系统

K号: K243283 · 2025-02-20

决定日期2025-02-20

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

Alinity h-series System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2025-02-20 under 510(k) number K243283. 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 Alinity h-series System?

Alinity h-series System is a medical device that received FDA 510(k) clearance on 2025-02-20. The listed applicant is Abbott Laboratories. The 510(k) number is K243283.

When did Alinity h-series System receive FDA 510(k) clearance?

Alinity h-series System received FDA 510(k) clearance on 2025-02-20, under 510(k) number K243283.

Who is the listed applicant for Alinity h-series System?

FDA 510(k)记录显示，申请人为阿伯特实验室。这本身并不能确立该设备的制造商。

What is the FDA product code for Alinity h-series System?

The FDA product code for Alinity h-series System is GKZ.

列明Abbott Laboratories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。

K262156抗HCV Next K252424抗HCV Next K243500ARCHITECT 链霉素 K243168Alinity i 风疹IgG K233932Alinity i Toxo IgM K232669TBI

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官方来源

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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。