SMART M-CELL Bone Marrow Concentration System— 510(k) K250518

Substantially Equivalent

Miracell Co., Ltd.

FDA 510(k) clearance K250518 for SMART M-CELL Bone Marrow Concentration System, Substantially Equivalent on 2026-04-02. Applicant: Miracell Co., Ltd..

Clearance details

Applicant: Miracell Co., Ltd.
Product code: Code QBV
Advisory panel: Clinical Chemistry
Date received: 2025-02-21
Decision date: 2026-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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