510(k) K251281
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 2026
- Date Received
- April 24, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Creatinine Test System For At Home Prescription Use
- Device Class
- Class II
- Regulation Number
- 862.1225
- Review Panel
- CH
- Submission Type
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.