NTZ

Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator

Product code

NTZ

Device name

Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator

Device class

Class 2

21 CFR

21 CFR 876.5820

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

Device provides semiquantitative indications of ph, bicarbonate ions, and glucose in the final bicarbonate dialysate.

Definition text from the FDA device classification database (U.S. federal government work, public domain).