Clearance Summary
SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set received FDA 510(k) clearance under submission number K193670, sponsored by Quanta Dialysis Technologies, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2020-12-23.
- Submission: K193670
- Applicant / Sponsor: Quanta Dialysis Technologies, Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5860
- Decision date: 2020-12-23
Classification & Regulation
This clearance is catalogued under FDA product code KDI and 21 CFR 876.5860, within the Gastroenterology, Urology review panel as a Class II device.