FDA 510(k)

HYDRASHIFT 2/4 daratumumab

K号: K190851 · 2019-05-02

申请人Sebia

决定日期2019-05-02

产品代码CFF

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决定实质等同

器械摘要

HYDRASHIFT 2/4 daratumumab is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2019-05-02 under 510(k) number K190851. The device is classified under product code CFF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HYDRASHIFT 2/4 daratumumab?

HYDRASHIFT 2/4 daratumumab is a medical device that received FDA 510(k) clearance on 2019-05-02. The listed applicant is Sebia. The 510(k) number is K190851.

When did HYDRASHIFT 2/4 daratumumab receive FDA 510(k) clearance?

HYDRASHIFT 2/4 daratumumab received FDA 510(k) clearance on 2019-05-02, under 510(k) number K190851.

Who is the listed applicant for HYDRASHIFT 2/4 daratumumab?

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

What is the FDA product code for HYDRASHIFT 2/4 daratumumab?

The FDA product code for HYDRASHIFT 2/4 daratumumab is CFF.

列明Sebia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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