FDA 510(k)

Access 游离T4

K号: K240273 · 2024-03-06

决定日期2024-03-06

产品代码CEC

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Access Free T4 is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-03-06 under 510(k) number K240273. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Access Free T4?

Access Free T4 is a medical device that received FDA 510(k) clearance on 2024-03-06. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K240273.

When did Access Free T4 receive FDA 510(k) clearance?

Access Free T4 received FDA 510(k) clearance on 2024-03-06, under 510(k) number K240273.

Who is the listed applicant for Access Free T4?

FDA 510(k)记录中列出Beckman Coulter, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Access Free T4?

The FDA product code for Access Free T4 is CEC.

列明Beckman Coulter, 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。

K262109Access NT-proBNP K252169Access BNP II K254059Access 乙型肝炎核心抗体IgM K253687Access 乙型肝炎核心抗体总抗体 K251995Access 乙型肝炎核心抗体IgM K250588Access 风疹IgG

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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。