FDA 510(k)

LIAISON VZV IgG HT，LIAISON 控制VZV IgG HT

K号: K231214 · 2023-10-27

决定日期2023-10-27

产品代码LFY

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决定实质等同

器械摘要

LIAISON VZV IgG HT, LIAISON Control VZV IgG HT is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K231214. The device is classified under product code LFY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LIAISON VZV IgG HT, LIAISON Control VZV IgG HT?

LIAISON VZV IgG HT, LIAISON Control VZV IgG HT is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is DiaSorin, Inc.. The 510(k) number is K231214.

When did LIAISON VZV IgG HT, LIAISON Control VZV IgG HT receive FDA 510(k) clearance?

LIAISON VZV IgG HT, LIAISON Control VZV IgG HT received FDA 510(k) clearance on 2023-10-27, under 510(k) number K231214.

Who is the listed applicant for LIAISON VZV IgG HT, LIAISON Control VZV IgG HT?

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 VZV IgG HT, LIAISON Control VZV IgG HT?

The FDA product code for LIAISON VZV IgG HT, LIAISON Control VZV IgG HT is LFY.

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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器械摘要

常见问题

相关临床试验

列明DiaSorin, Inc.为申报人的其他记录

官方来源