FDA 510(k)

ARIES MRSA 测试

K号: K191742 · 2019-09-25

决定日期2019-09-25

产品代码NQX

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决定实质等同

器械摘要

ARIES MRSA Assay is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Corporation. It received FDA 510(k) clearance on 2019-09-25 under 510(k) number K191742. The device is classified under product code NQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ARIES MRSA Assay?

ARIES MRSA Assay is a medical device that received FDA 510(k) clearance on 2019-09-25. The listed applicant is Luminex Corporation. The 510(k) number is K191742.

When did ARIES MRSA Assay receive FDA 510(k) clearance?

ARIES MRSA Assay received FDA 510(k) clearance on 2019-09-25, under 510(k) number K191742.

Who is the listed applicant for ARIES MRSA Assay?

The FDA 510(k) record lists Luminex Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARIES MRSA Assay?

The FDA product code for ARIES MRSA Assay is NQX.

列明Luminex Corporation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。

K253722LIAISON PLEX 胃肠道灵活检测 K243490LIAISON PLEX 革兰氏阳性血培养检测 K243013LIAISON PLEX 革兰氏阴性血培养检测 K240627LIAISON PLEX 酵母血培养检测 K233410LIAISON PLEX 呼吸道灵活检测 K172402ARIES Group A Strep 测试，ARIES Group A Strep 测试方案文件包

查看所有 13 个设备 →

官方来源

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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。