NTZ — Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator Class II
FDA product code NTZ covers "Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K043031 | serim research | SERIM DIALYSATE MONITOR TEST STRIP | June 13, 2005 |