FDA 510(k)

LIAISON Anti-HAV Assay

K号: K193532 · 2020-03-02

决定日期2020-03-02

产品代码LOL

咨询委员会抱歉，您提供的内容“MI”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

LIAISON Anti-HAV Assay is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2020-03-02 under 510(k) number K193532. 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 Anti-HAV Assay?

LIAISON Anti-HAV Assay is a medical device that received FDA 510(k) clearance on 2020-03-02. The listed applicant is DiaSorin, Inc.. The 510(k) number is K193532.

When did LIAISON Anti-HAV Assay receive FDA 510(k) clearance?

LIAISON Anti-HAV Assay received FDA 510(k) clearance on 2020-03-02, under 510(k) number K193532.

Who is the listed applicant for LIAISON Anti-HAV Assay?

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 Anti-HAV Assay?

The FDA product code for LIAISON Anti-HAV Assay is LOL.

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。

K260770LIAISON Murex HBsAg Qual；LIAISON XL；LIAISON 稀释X K231214LIAISON VZV IgG HT，LIAISON 控制VZV IgG HT K223403LIAISON Anti-HAV; LIAISON XS K213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus K213936LIAISON MeMed BV，LIAISON MeMed BV控制套件 K193650LIAISON Ferritin

查看所有 25 个设备 →

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。