FDA 510(k)

Access 风疹IgG

K号: K250588 · 2025-11-17

决定日期2025-11-17

产品代码LFX

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决定实质等同

器械摘要

Access Rubella IgG 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 2025-11-17 under 510(k) number K250588. The device is classified under product code LFX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Access Rubella IgG?

Access Rubella IgG is a medical device that received FDA 510(k) clearance on 2025-11-17. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K250588.

When did Access Rubella IgG receive FDA 510(k) clearance?

Access Rubella IgG received FDA 510(k) clearance on 2025-11-17, under 510(k) number K250588.

Who is the listed applicant for Access Rubella IgG?

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 Rubella IgG?

The FDA product code for Access Rubella IgG is LFX.

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 K252580iQ200系列

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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。