NTZ — Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator Class II

FDA Device Classification

Classification Details

Product Code
NTZ
Device Class
Class II
Regulation Number
876.5820
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K043031serim researchSERIM DIALYSATE MONITOR TEST STRIPJune 13, 2005