FDA 510(k)

Curian HpSA，Curian 分析仪

K号: K192817 · 2020-03-13

决定日期2020-03-13

产品代码LYR

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决定实质等同

器械摘要

Curian HpSA, Curian Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2020-03-13 under 510(k) number K192817. 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 Curian HpSA, Curian Analyzer?

Curian HpSA, Curian Analyzer is a medical device that received FDA 510(k) clearance on 2020-03-13. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K192817.

When did Curian HpSA, Curian Analyzer receive FDA 510(k) clearance?

Curian HpSA, Curian Analyzer received FDA 510(k) clearance on 2020-03-13, under 510(k) number K192817.

Who is the listed applicant for Curian HpSA, Curian Analyzer?

The FDA 510(k) record lists Meridian Bioscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Curian HpSA, Curian Analyzer?

The FDA product code for Curian HpSA, Curian Analyzer is LYR.

列明Meridian Bioscience, 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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