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FDA 510(k)

LIAISON HAV IgM, LIAISON Control HAV IgM

K号: K160650 · 2016-08-25

决定日期2016-08-25
产品代码LOL
咨询委员会MI
决定Substantially Equivalent

器械摘要

LIAISON HAV IgM, LIAISON Control HAV IgM is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2016-08-25 under 510(k) number K160650. The device is classified under product code LOL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LIAISON HAV IgM, LIAISON Control HAV IgM?

LIAISON HAV IgM, LIAISON Control HAV IgM is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is DiaSorin, Inc.. The 510(k) number is K160650.

When did LIAISON HAV IgM, LIAISON Control HAV IgM receive FDA 510(k) clearance?

LIAISON HAV IgM, LIAISON Control HAV IgM received FDA 510(k) clearance on 2016-08-25, under 510(k) number K160650.

Who is the listed applicant for LIAISON HAV IgM, LIAISON Control HAV IgM?

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 HAV IgM, LIAISON Control HAV IgM?

The FDA product code for LIAISON HAV IgM, LIAISON Control HAV IgM is LOL.

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列明DiaSorin, Inc.为申报人的其他记录

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相关器械(代码:LOL)

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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