Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
The Dialysate pH, Bicarbonate, Glucose, and Acid Indicator Strip is a semiquantitative test device that provides indications of pH, bicarbonate ions, and glucose levels in final bicarbonate dialysate, used to verify dialysate composition prior to hemodialysis treatments. Proper dialysate chemistry is critical for safe dialysis procedures. It is an FDA Class 2 device regulated under 21 CFR 876.5820 in the Gastroenterology and Urology specialty, with product code NTZ, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.
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Basic Information
- Product Code
- NTZ
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
Device provides semiquantitative indications of ph, bicarbonate ions, and glucose in the final bicarbonate dialysate.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K043031 | SERIM DIALYSATE MONITOR TEST STRIP | Jun 13, 2005 | Substantially Equivalent | Serim Research Corp. |