FDA 510(k)

HYDRASHIFT 2/4 isatuximab

K号: K203184 · 2021-11-12

申请人Sebia

决定日期2021-11-12

产品代码CFF

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决定实质等同

器械摘要

HYDRASHIFT 2/4 isatuximab is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2021-11-12 under 510(k) number K203184. 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 isatuximab?

HYDRASHIFT 2/4 isatuximab is a medical device that received FDA 510(k) clearance on 2021-11-12. The listed applicant is Sebia. The 510(k) number is K203184.

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

HYDRASHIFT 2/4 isatuximab received FDA 510(k) clearance on 2021-11-12, under 510(k) number K203184.

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

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 isatuximab?

The FDA product code for HYDRASHIFT 2/4 isatuximab 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。

K232027CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument K231601FLC Kappa，FLC Lambda，FLC 控制级别 1，FLC 控制级别 2 K210623FLC Kappa，FLC Lambda，FLC 控制级别 1，FLC 控制级别 2 K192095CAPI 3 Immunotyping, Capillarys 3 Tera K190851HYDRASHIFT 2/4 daratumumab K180762CAPI 3 HEMOGLOBIN(E)

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