FDA 510(k)

ARX 液體阿米斯收集與運輸系統

K 號：K222613 · 2024-03-27

決定日期2024-03-27

產品代碼LIO

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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.

其他以 Arx Sciences, Inc. 為申請人之記錄

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K231843ARX病毒傳輸培養基收集和運輸系統

官方來源

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器材摘要

常見問題

相關臨床試驗

其他以 Arx Sciences, Inc. 為申請人之記錄

官方來源