FDA 510(k)

PREMIER铂金HpSA PLUS

K号: K182559 · 2018-11-05

决定日期2018-11-05

产品代码LYR

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

PREMIER Platinum HpSA PLUS 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 2018-11-05 under 510(k) number K182559. 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 Platinum HpSA PLUS?

PREMIER Platinum HpSA PLUS is a medical device that received FDA 510(k) clearance on 2018-11-05. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K182559.

When did PREMIER Platinum HpSA PLUS receive FDA 510(k) clearance?

PREMIER Platinum HpSA PLUS received FDA 510(k) clearance on 2018-11-05, under 510(k) number K182559.

Who is the listed applicant for PREMIER Platinum HpSA PLUS?

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 Platinum HpSA PLUS?

The FDA product code for PREMIER Platinum HpSA PLUS 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 K230901Premier HpSA Flex (619096)K222829Curian® Shiga Toxin K222779Revogene K220480Revogene K210976Curian Campy

查看所有 11 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。