FDA 510(k)

Access 乙型肝炎表面抗原抗体

K号: K243846 · 2025-09-09

决定日期2025-09-09

产品代码LOL

咨询委员会抱歉，您提供的内容“MI”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 anti-HAV 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 2025-09-09 under 510(k) number K243846. The device is classified under product code LOL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Access anti-HAV?

Access anti-HAV is a medical device that received FDA 510(k) clearance on 2025-09-09. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K243846.

When did Access anti-HAV receive FDA 510(k) clearance?

Access anti-HAV received FDA 510(k) clearance on 2025-09-09, under 510(k) number K243846.

Who is the listed applicant for Access anti-HAV?

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 anti-HAV?

The FDA product code for Access anti-HAV is LOL.

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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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。