FDA 510(k)

Atellica IM 铁蛋白测定

K号: K171642 · 2017-08-31

决定日期2017-08-31

产品代码DBF

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决定实质等同

器械摘要

Atellica IM Ferritin Assay 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 2017-08-31 under 510(k) number K171642. The device is classified under product code DBF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Atellica IM Ferritin Assay?

Atellica IM Ferritin Assay is a medical device that received FDA 510(k) clearance on 2017-08-31. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K171642.

When did Atellica IM Ferritin Assay receive FDA 510(k) clearance?

Atellica IM Ferritin Assay received FDA 510(k) clearance on 2017-08-31, under 510(k) number K171642.

Who is the listed applicant for Atellica IM Ferritin Assay?

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 IM Ferritin Assay?

The FDA product code for Atellica IM Ferritin Assay is DBF.

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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