FDA 510(k)

FREND PSA PLUS (试剂盒)

K号: K162378 · 2017-05-17

决定日期2017-05-17

产品代码LTJ

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决定实质等同

器械摘要

FREND PSA PLUS (reagent cartridge) 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 2017-05-17 under 510(k) number K162378. The device is classified under product code LTJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FREND PSA PLUS (reagent cartridge)?

FREND PSA PLUS (reagent cartridge) is a medical device that received FDA 510(k) clearance on 2017-05-17. The listed applicant is Nanoentek USA, Inc.. The 510(k) number is K162378.

When did FREND PSA PLUS (reagent cartridge) receive FDA 510(k) clearance?

FREND PSA PLUS (reagent cartridge) received FDA 510(k) clearance on 2017-05-17, under 510(k) number K162378.

Who is the listed applicant for FREND PSA PLUS (reagent cartridge)?

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 PSA PLUS (reagent cartridge)?

The FDA product code for FREND PSA PLUS (reagent cartridge) is LTJ.

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。

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