FDA 510(k)

IMMULITE/IMMULITE® 1000 皮质醇

K号: K203270 · 2021-01-15

申请人Siemens Healthcare Diagnostics Products, Ltd.

决定日期2021-01-15

产品代码CGR

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

IMMULITE/IMMULITE® 1000 Cortisol is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products, Ltd.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K203270. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IMMULITE/IMMULITE® 1000 Cortisol?

IMMULITE/IMMULITE® 1000 Cortisol is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Siemens Healthcare Diagnostics Products, Ltd.. The 510(k) number is K203270.

When did IMMULITE/IMMULITE® 1000 Cortisol receive FDA 510(k) clearance?

IMMULITE/IMMULITE® 1000 Cortisol received FDA 510(k) clearance on 2021-01-15, under 510(k) number K203270.

Who is the listed applicant for IMMULITE/IMMULITE® 1000 Cortisol?

FDA 510(k)记录中列出西门子医疗诊断产品有限公司为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for IMMULITE/IMMULITE® 1000 Cortisol?

The FDA product code for IMMULITE/IMMULITE® 1000 Cortisol is CGR.

列明Siemens Healthcare Diagnostics Products, Ltd.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。

K260331IMMULITE 2000 3g过敏特异性IgE Vantage；IMMULITE 2000系统花生过敏原（F13）K233946IMMULITE® 2000 BR-MA K213510IMMULITE/IMMULITE 1000 OM-MA，IMMULITE 2000 OM-MA K202826IMMULITE® 2000 皮质醇

官方来源

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