K250518
- 510(k) number
- K250518
- Device name
- SMART M-CELL Bone Marrow Concentration System
- Applicant
- Miracell Co., Ltd. KR
- Product code
- QBV — Centrifuge For Preparation Of Cell Concentrate And/O
- Decision date
- 2026-04-02
- Date received
- 2025-02-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250518.pdf
Official FDA record: K250518
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.