FDA 510(k)

Elecsys FT4 IV

K号: K220456 · 2023-04-07

决定日期2023-04-07

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

Elecsys FT4 IV is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2023-04-07 under 510(k) number K220456. 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 Elecsys FT4 IV?

Elecsys FT4 IV is a medical device that received FDA 510(k) clearance on 2023-04-07. The listed applicant is Roche Diagnostics. The 510(k) number is K220456.

When did Elecsys FT4 IV receive FDA 510(k) clearance?

Elecsys FT4 IV received FDA 510(k) clearance on 2023-04-07, under 510(k) number K220456.

Who is the listed applicant for Elecsys FT4 IV?

FDA 510(k)记录显示罗氏诊断公司为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Elecsys FT4 IV?

The FDA product code for Elecsys FT4 IV is CEC.

列明Roche Diagnostics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。

K261686Elecsys 磷酸-Tau（217P）血浆 K252323科博斯脉搏血糖监测系统 K252280Elecsys 抗-SARS-CoV-2 S K260049Elecsys Anti-HBc IgM K260048Elecsys Anti-HAV IgM K260046Elecsys Anti-HBc II

查看所有 69 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。