FDA 510(k)

Atellica CH 胰岛素_2 (AMY_2)

K号: K191454 · 2019-07-30

决定日期2019-07-30

产品代码JFJ

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

Atellica CH Amylase_2 (AMY_2) 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 2019-07-30 under 510(k) number K191454. The device is classified under product code JFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Atellica CH Amylase_2 (AMY_2)?

Atellica CH Amylase_2 (AMY_2) is a medical device that received FDA 510(k) clearance on 2019-07-30. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K191454.

When did Atellica CH Amylase_2 (AMY_2) receive FDA 510(k) clearance?

Atellica CH Amylase_2 (AMY_2) received FDA 510(k) clearance on 2019-07-30, under 510(k) number K191454.

Who is the listed applicant for Atellica CH Amylase_2 (AMY_2)?

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 Amylase_2 (AMY_2)?

The FDA product code for Atellica CH Amylase_2 (AMY_2) is JFJ.

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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