NTZ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- Device provides semiquantitative indications of ph, bicarbonate ions, and glucose in the final bicarbonate dialysate.
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| Record | Firm | Date |
|---|---|---|
| SERIM DIALYSATE MONITOR TEST STRIP (K043031) | Serim Research Corp. | 2005-06-13 |
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Every clearance here is in the API, with alerts when new ones post.