DeviceClearance

Product code NTZ— Gastroenterology, Urology

SERIM DIALYSATE MONITOR TEST STRIP

Classification name
Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code NTZ under 21 CFR 876.5820, via openFDA

Market context for product code NTZ

FDA has cleared 1 device under product code NTZ, all in 2005, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NTZ

Recent clearances under product code NTZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.