FDA 510(k)

Premier HpSA Flex (619096)

K号: K230901 · 2023-07-03

决定日期2023-07-03

产品代码LYR

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决定实质等同

器械摘要

Premier HpSA Flex (619096) 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 2023-07-03 under 510(k) number K230901. 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 Premier HpSA Flex (619096)?

Premier HpSA Flex (619096) is a medical device that received FDA 510(k) clearance on 2023-07-03. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K230901.

When did Premier HpSA Flex (619096) receive FDA 510(k) clearance?

Premier HpSA Flex (619096) received FDA 510(k) clearance on 2023-07-03, under 510(k) number K230901.

Who is the listed applicant for Premier HpSA Flex (619096)?

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 Premier HpSA Flex (619096)?

The FDA product code for Premier HpSA Flex (619096) 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。

K243922Revogene K222829Curian® Shiga Toxin K222779Revogene K220480Revogene K210976Curian Campy K192817Curian HpSA，Curian 分析仪

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