FDA 510(k)

Synermed 葡萄糖试剂，Synermed IR-1200 化学分析仪

K号: K153692 · 2016-06-24

申请人Infrared Laboratory Systems, LLC (Dba Synermed)

决定日期2016-06-24

产品代码CGA

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

Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Infrared Laboratory Systems, LLC (Dba Synermed). It received FDA 510(k) clearance on 2016-06-24 under 510(k) number K153692. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer?

Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Infrared Laboratory Systems, LLC (Dba Synermed). The 510(k) number is K153692.

When did Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer receive FDA 510(k) clearance?

Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer received FDA 510(k) clearance on 2016-06-24, under 510(k) number K153692.

Who is the listed applicant for Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer?

The FDA 510(k) record lists Infrared Laboratory Systems, LLC (Dba Synermed) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer?

The FDA product code for Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer is CGA.

列明Infrared Laboratory Systems, LLC (Dba Synermed)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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