Source document or public record
FDA 510(k) K200530 — AMICUS Separator System
FDA 510(k) index record K200530. Device: AMICUS Separator System. Applicant as listed: Fresenius Kabi AG. Decision date: 2020-09-11.
Source
"device_name": "AMICUS Separator System"
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 K200530.
Device name: AMICUS Separator System. Applicant as listed: Fresenius Kabi AG.
Decision date: 2020-09-11. Decision wording: Substantially Equivalent.
Product code: GKT. Regulation: 21 CFR 864.9245. Medical specialty: Hematology.
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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