Clearance Summary
HYDRASHIFT 2/4 daratumumab received FDA 510(k) clearance under submission number K190851, sponsored by Sebia. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2019-05-02.
- Submission: K190851
- Applicant / Sponsor: Sebia
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5510
- Decision date: 2019-05-02
Classification & Regulation
This clearance is catalogued under FDA product code CFF and 21 CFR 866.5510, within the Immunology review panel as a Class II device.