FDA 510(k)

迪亞茲美1,5-AG測試

K 號：K180209 · 2018-10-04

決定日期2018-10-04

產品代碼NOZ

諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。

決定相當於

器材摘要

Diazyme 1,5-AG Assay is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories, Inc.. It received FDA 510(k) clearance on 2018-10-04 under 510(k) number K180209. The device is classified under product code NOZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Diazyme 1,5-AG Assay?

Diazyme 1,5-AG Assay is a medical device that received FDA 510(k) clearance on 2018-10-04. The listed applicant is Diazyme Laboratories, Inc.. The 510(k) number is K180209.

When did Diazyme 1,5-AG Assay receive FDA 510(k) clearance?

Diazyme 1,5-AG Assay received FDA 510(k) clearance on 2018-10-04, under 510(k) number K180209.

Who is the listed applicant for Diazyme 1,5-AG Assay?

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

What is the FDA product code for Diazyme 1,5-AG Assay?

The FDA product code for Diazyme 1,5-AG Assay is NOZ.

其他以 Diazyme Laboratories, Inc. 為申請人之記錄

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器材摘要

常見問題

相關臨床試驗

其他以 Diazyme Laboratories, Inc. 為申請人之記錄

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