Source document or public record
FDA 510(k) K250518 — SMART M-CELL Bone Marrow Concentration System
FDA 510(k) index record K250518. Device: SMART M-CELL Bone Marrow Concentration System. Applicant as listed: Miracell Co., Ltd.. Decision date: 2026-04-02.
Source
"device_name": "SMART M-CELL Bone Marrow Concentration 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 K250518.
Device name: SMART M-CELL Bone Marrow Concentration System. Applicant as listed: Miracell Co., Ltd..
Decision date: 2026-04-02. Decision wording: Substantially Equivalent.
Product code: QBV. Regulation: 21 CFR 862.2050. Medical specialty: Clinical Chemistry.
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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