Source document or public record
FDA 510(k) K203184 — HYDRASHIFT 2/4 isatuximab
FDA 510(k) index record K203184. Device: HYDRASHIFT 2/4 isatuximab. Applicant as listed: Sebia. Decision date: 2021-11-12.
Source
"device_name": "HYDRASHIFT 2/4 isatuximab"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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2026-10-20
2026-10-20
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FDA 510(k) public index record K203184.
Device name: HYDRASHIFT 2/4 isatuximab. Applicant as listed: Sebia.
Decision date: 2021-11-12. Decision wording: Substantially Equivalent.
Product code: CFF. Regulation: 21 CFR 866.5510. Medical specialty: Immunology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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