FDA 510(k)

LIAISON 测试睾酮 xt

K号: K201908 · 2020-10-15

决定日期2020-10-15

产品代码CDZ

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决定实质等同

器械摘要

LIAISON Testosterone xt is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2020-10-15 under 510(k) number K201908. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LIAISON Testosterone xt?

LIAISON Testosterone xt is a medical device that received FDA 510(k) clearance on 2020-10-15. The listed applicant is DiaSorin, Inc.. The 510(k) number is K201908.

When did LIAISON Testosterone xt receive FDA 510(k) clearance?

LIAISON Testosterone xt received FDA 510(k) clearance on 2020-10-15, under 510(k) number K201908.

Who is the listed applicant for LIAISON Testosterone xt?

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

What is the FDA product code for LIAISON Testosterone xt?

The FDA product code for LIAISON Testosterone xt is CDZ.

列明DiaSorin, 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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