HYDRASHIFT 2/4 isatuximab— 510(k) K203184

Substantially Equivalent

Sebia

FDA 510(k) clearance K203184 for HYDRASHIFT 2/4 isatuximab, Substantially Equivalent on 2021-11-12. Applicant: Sebia.

Clearance details

Applicant: Sebia
Product code: Code CFF
Advisory panel: Immunology
Date received: 2020-10-27
Decision date: 2021-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

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