FDA 510(k)

Atellica® CH 高敏C反应蛋白2 (hCRP2)

K号: K233242 · 2024-01-18

决定日期2024-01-18

产品代码NQD

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决定实质等同

器械摘要

Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-01-18 under 510(k) number K233242. The device is classified under product code NQD. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)?

Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) is a medical device that received FDA 510(k) clearance on 2024-01-18. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K233242.

When did Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) receive FDA 510(k) clearance?

Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) received FDA 510(k) clearance on 2024-01-18, under 510(k) number K233242.

Who is the listed applicant for Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)?

FDA 510(k)记录中列出西门子医疗诊断公司（Siemens Healthcare Diagnostics, Inc.）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 Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)?

The FDA product code for Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) is NQD.

列明Siemens Healthcare Diagnostics, 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。

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