FDA 510(k)

ADVIA 化学酶法血红蛋白Ale (Alc_E) 测定

K号: K200256 · 2021-07-02

决定日期2021-07-02

产品代码PDJ

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

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) 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 2021-07-02 under 510(k) number K200256. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay?

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K200256.

When did ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay receive FDA 510(k) clearance?

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay received FDA 510(k) clearance on 2021-07-02, under 510(k) number K200256.

Who is the listed applicant for ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) 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 ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay?

The FDA product code for ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay is PDJ.

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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相关器械（代码：PDJ）

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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