FDA 510(k)

LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set

K号: K161139 · 2016-07-22

决定日期2016-07-22

产品代码LYR

咨询委员会MI

决定Substantially Equivalent

器械摘要

LIAISON H. pylori IgG, LIAISON H. pylori IgG 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 2016-07-22 under 510(k) number K161139. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set?

LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set is a medical device that received FDA 510(k) clearance on 2016-07-22. The listed applicant is DiaSorin, Inc.. The 510(k) number is K161139.

When did LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set receive FDA 510(k) clearance?

LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set received FDA 510(k) clearance on 2016-07-22, under 510(k) number K161139.

Who is the listed applicant for LIAISON H. pylori IgG, LIAISON H. pylori IgG 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 H. pylori IgG, LIAISON H. pylori IgG Control Set?

The FDA product code for LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set is LYR.

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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