FDA 510(k)

Elecsys HCG STAT

K号: K203227 · 2021-08-18

决定日期2021-08-18

产品代码DHA

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 HCG STAT is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2021-08-18 under 510(k) number K203227. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Elecsys HCG STAT?

Elecsys HCG STAT is a medical device that received FDA 510(k) clearance on 2021-08-18. The listed applicant is Roche Diagnostics. The 510(k) number is K203227.

When did Elecsys HCG STAT receive FDA 510(k) clearance?

Elecsys HCG STAT received FDA 510(k) clearance on 2021-08-18, under 510(k) number K203227.

Who is the listed applicant for Elecsys HCG STAT?

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 HCG STAT?

The FDA product code for Elecsys HCG STAT is DHA.

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。

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相关器械（代码：DHA）

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。

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