Definition: DEVICE PROVIDES SEMIQUANTITATIVE INDICATIONS OF PH, BICARBONATE IONS, AND GLUCOSE IN THE FINAL BICARBONATE DIALYSATE.
| Device Type ID | 2046 |
| Device Name | Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator |
| Regulation Description | Hemodialysis System And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5820 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NTZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 2046 |
| Device | Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator |
| Product Code | NTZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hemodialysis System And Accessories. |
| CFR Regulation Number | 876.5820 [🔎] |