FDA 510(k)

特立尼达CH万古霉素（Vanc），特立尼达CH药物3校准器（DRUG3 CAL）

K号: K160202 · 2016-04-27

决定日期2016-04-27

产品代码LEH

咨询委员会TX 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) 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 2016-04-27 under 510(k) number K160202. The device is classified under product code LEH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)?

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) is a medical device that received FDA 510(k) clearance on 2016-04-27. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K160202.

When did Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) receive FDA 510(k) clearance?

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) received FDA 510(k) clearance on 2016-04-27, under 510(k) number K160202.

Who is the listed applicant for Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)?

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 Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)?

The FDA product code for Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) is LEH.

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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官方来源

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