Medical Device Manufacturer · GB , Alcester

Quanta Dialysis Technologies, Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2020

Recent clearances: SC+ Hemodialysis Device (SC-14269), SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set, SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Quanta Dialysis Technologies, Ltd. Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared Nov 01, 2024

SC+ Hemodialysis Device (SC-14269)

Gastroenterology & Urology · 92d

Cleared Nov 10, 2022

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set

Gastroenterology & Urology · 120d

Cleared Aug 12, 2021

SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset

Gastroenterology & Urology · 161d

Cleared Dec 23, 2020

SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set

Gastroenterology & Urology · 358d