Quanta Dialysis Technologies, Ltd. FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)510(k)Nov 1, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Nov 1, 2024
SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set510(k)Nov 10, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Nov 10, 2022
SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset510(k)Aug 12, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Aug 12, 2021