FDA 510(k)

FREND 测试睾酮测试系统

K号: K153577 · 2016-10-14

决定日期2016-10-14

产品代码CDZ

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

FREND Testosterone Test System is the device name listed in this FDA 510(k) record. The listed applicant is Nanoentek USA, Inc.. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K153577. 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 FREND Testosterone Test System?

FREND Testosterone Test System is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Nanoentek USA, Inc.. The 510(k) number is K153577.

When did FREND Testosterone Test System receive FDA 510(k) clearance?

FREND Testosterone Test System received FDA 510(k) clearance on 2016-10-14, under 510(k) number K153577.

Who is the listed applicant for FREND Testosterone Test System?

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

What is the FDA product code for FREND Testosterone Test System?

The FDA product code for FREND Testosterone Test System is CDZ.

列明Nanoentek USA, 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。

K162378FREND PSA PLUS (试剂盒)K162754FREND 维生素D测试系统 K152422FREND™ 游离T4测试系统

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