SHB
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Creatinine Test System For At Home Prescription Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1225
- Medical specialty
- Clinical Chemistry
- FDA definition
- For the quantitative measurement of creatinine in home use settings by patients as an aid to monitor kidney function. This device is for prescription use only.
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| Record | Firm | Date |
|---|---|---|
| Nova Max Creat eGFR Monitoring System (K251281) | Nova Biomedical Corporation | 2026-01-21 |
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