FDA 510(k)

LIAISON® EA IgG和LIAISON® EA IgG血清控制套件

K号: K162959 · 2017-01-04

决定日期2017-01-04

产品代码LSE

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决定实质等同

器械摘要

LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2017-01-04 under 510(k) number K162959. The device is classified under product code LSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set?

LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set is a medical device that received FDA 510(k) clearance on 2017-01-04. The listed applicant is DiaSorin, Inc.. The 510(k) number is K162959.

When did LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set receive FDA 510(k) clearance?

LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set received FDA 510(k) clearance on 2017-01-04, under 510(k) number K162959.

Who is the listed applicant for LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set?

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® EA IgG and LIAISON® EA IgG Serum Control Set?

The FDA product code for LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set is LSE.

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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