Product code SHB
- Device name
- Creatinine Test System For At Home Prescription Use
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1225
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K251281 | Nova Max Creat eGFR Monitoring System | Nova Biomedical Corporation | 2026-01-21 |