FDA 510(k)

二氧化碳试剂套装

K号: K170200 · 2017-06-01

决定日期2017-06-01

产品代码KHS

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

Carbon Dioxide Reagent Set is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-06-01 under 510(k) number K170200. The device is classified under product code KHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Carbon Dioxide Reagent Set?

Carbon Dioxide Reagent Set is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Teco Diagnostics, Inc.. The 510(k) number is K170200.

When did Carbon Dioxide Reagent Set receive FDA 510(k) clearance?

Carbon Dioxide Reagent Set received FDA 510(k) clearance on 2017-06-01, under 510(k) number K170200.

Who is the listed applicant for Carbon Dioxide Reagent Set?

The FDA 510(k) record lists Teco Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Carbon Dioxide Reagent Set?

The FDA product code for Carbon Dioxide Reagent Set is KHS.

列明Teco 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。

K161527Teco Creatinine Enzymatic Reagent Kit K160372URITEK TC-201 尿液化学检测系统 K152835URITEK TC-201 尿液化学检测系统

官方来源

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