FDA 510(k)

Access 皮质醇

K号: K223038 · 2023-02-08

决定日期2023-02-08

产品代码CGR

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 Cortisol 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 2023-02-08 under 510(k) number K223038. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Access Cortisol?

Access Cortisol is a medical device that received FDA 510(k) clearance on 2023-02-08. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K223038.

When did Access Cortisol receive FDA 510(k) clearance?

Access Cortisol received FDA 510(k) clearance on 2023-02-08, under 510(k) number K223038.

Who is the listed applicant for Access Cortisol?

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 Cortisol?

The FDA product code for Access Cortisol is CGR.

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

查看所有 73 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。