FDA 510(k)

ARX 液体 Amies 收集与运输系统

K号: K222613 · 2024-03-27

决定日期2024-03-27

产品代码LIO

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决定实质等同

器械摘要

ARX Liquid Amies Collection & Transport System is the device name listed in this FDA 510(k) record. The listed applicant is Arx Sciences, Inc.. It received FDA 510(k) clearance on 2024-03-27 under 510(k) number K222613. The device is classified under product code LIO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ARX Liquid Amies Collection & Transport System?

ARX Liquid Amies Collection & Transport System is a medical device that received FDA 510(k) clearance on 2024-03-27. The listed applicant is Arx Sciences, Inc.. The 510(k) number is K222613.

When did ARX Liquid Amies Collection & Transport System receive FDA 510(k) clearance?

ARX Liquid Amies Collection & Transport System received FDA 510(k) clearance on 2024-03-27, under 510(k) number K222613.

Who is the listed applicant for ARX Liquid Amies Collection & Transport System?

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

What is the FDA product code for ARX Liquid Amies Collection & Transport System?

The FDA product code for ARX Liquid Amies Collection & Transport System is LIO.

列明Arx Sciences, 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。

K231843ARX 病毒运输介质收集与运输系统

官方来源

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器械摘要

常见问题

相关临床试验

列明Arx Sciences, Inc.为申报人的其他记录

官方来源