FDA 510(k)

Access CEA

K号: K223921 · 2023-09-22

决定日期2023-09-22

产品代码DHX

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决定实质等同

器械摘要

Access CEA 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 2023-09-22 under 510(k) number K223921. The device is classified under product code DHX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Access CEA?

Access CEA is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K223921.

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

Access CEA received FDA 510(k) clearance on 2023-09-22, under 510(k) number K223921.

Who is the listed applicant for Access CEA?

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 CEA?

The FDA product code for Access CEA is DHX.

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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