FDA 510(k)

Xpert Carba-R

K号: K261867 · 2026-07-02

决定日期2026-07-02

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 2026-07-02 under 510(k) number K261867. 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 2026-07-02. The listed applicant is Cepheid®. The 510(k) number is K261867.

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

Xpert Carba-R received FDA 510(k) clearance on 2026-07-02, under 510(k) number K261867.

Who is the listed applicant for Xpert Carba-R?

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

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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