FDA 510(k)

LIAISON 洛基螺杆菌抗原，LIAISON 洛基螺杆菌抗原控制套件

K号: K181464 · 2018-08-31

决定日期2018-08-31

产品代码LYR

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决定实质等同

器械摘要

LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen 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 2018-08-31 under 510(k) number K181464. 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 Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set?

LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set is a medical device that received FDA 510(k) clearance on 2018-08-31. The listed applicant is DiaSorin, Inc.. The 510(k) number is K181464.

When did LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set receive FDA 510(k) clearance?

LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set received FDA 510(k) clearance on 2018-08-31, under 510(k) number K181464.

Who is the listed applicant for LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen 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 Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set?

The FDA product code for LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen 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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