FDA 510(k)

Xpert GBS LB XC，GeneXpert Dx 系统，GeneXpert Infinity 系统

K号: K203429 · 2022-05-09

决定日期2022-05-09

产品代码NJR

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

Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2022-05-09 under 510(k) number K203429. The device is classified under product code NJR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System?

Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System is a medical device that received FDA 510(k) clearance on 2022-05-09. The listed applicant is Cepheid. The 510(k) number is K203429.

When did Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System receive FDA 510(k) clearance?

Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System received FDA 510(k) clearance on 2022-05-09, under 510(k) number K203429.

Who is the listed applicant for Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System?

FDA 510(k)记录中列出Cepheid为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System?

The FDA product code for Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System is NJR.

列明Cepheid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。

K261336Xpert呼吸检测板 K261362Xpert 出血热检测设备 K261867Xpert Carba-R K253653Xpert 出血热检测设备 K251721Xpert GI 面板 K250996Xpert Xpress CoV-2/流感/RSV plus

查看所有 38 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。