FDA 510(k)

PixoTest POCT系统 - PixoTest POCT分析仪和PixoTest A1c测试套件

K号: K192369 · 2019-10-29

决定日期2019-10-29

产品代码LCP

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决定实质等同

器械摘要

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit is the device name listed in this FDA 510(k) record. The listed applicant is Ixensor Co, Ltd.. It received FDA 510(k) clearance on 2019-10-29 under 510(k) number K192369. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit?

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit is a medical device that received FDA 510(k) clearance on 2019-10-29. The listed applicant is Ixensor Co, Ltd.. The 510(k) number is K192369.

When did PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit receive FDA 510(k) clearance?

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit received FDA 510(k) clearance on 2019-10-29, under 510(k) number K192369.

Who is the listed applicant for PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit?

The FDA 510(k) record lists Ixensor Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit?

The FDA product code for PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit is LCP.

列明Ixensor Co, Ltd.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。

K181915PixoTest POCT系统 - PixoTest POCT分析仪和PixoTest A1c测试套件

官方来源

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