Clearance Summary
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit received FDA 510(k) clearance under submission number K201814, sponsored by Becton, Dickinson and Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2020-09-28.
- Submission: K201814
- Applicant / Sponsor: Becton, Dickinson and Company
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5220
- Decision date: 2020-09-28
Classification & Regulation
This clearance is catalogued under FDA product code OYE and 21 CFR 864.5220, within the Hematology review panel as a Class II device.