FDA 510(k)

Xpert Carba-R

K号: K160901 · 2016-06-29

决定日期2016-06-29

产品代码POC

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决定实质等同

器械摘要

Xpert Carba-R is the device name listed in this FDA 510(k) record. The listed applicant is Cepheid. It received FDA 510(k) clearance on 2016-06-29 under 510(k) number K160901. The device is classified under product code POC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Xpert Carba-R?

Xpert Carba-R is a medical device that received FDA 510(k) clearance on 2016-06-29. The listed applicant is Cepheid. The 510(k) number is K160901.

When did Xpert Carba-R receive FDA 510(k) clearance?

Xpert Carba-R received FDA 510(k) clearance on 2016-06-29, under 510(k) number K160901.

Who is the listed applicant for Xpert Carba-R?

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 Carba-R?

The FDA product code for Xpert Carba-R is POC.

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。

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