FDA 510(k)

Diazyme 1,5-AG 测定

K号: K180209 · 2018-10-04

决定日期2018-10-04

产品代码NOZ

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决定实质等同

器械摘要

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.

常见问题

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.

列明Diazyme Laboratories, 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。

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器械摘要

常见问题

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列明Diazyme Laboratories, Inc.为申报人的其他记录

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