510(k) K251281
K251281 is an FDA 510(k) premarket notification submitted by Nova Biomedical Corporation for the device "Nova Max Creat eGFR Monitoring System". The FDA issued a decision of Substantially Equivalent on January 21, 2026. The device falls under product code SHB (Creatinine Test System For At Home Prescription Use), a Class II device regulated under 21 CFR 862.1225. Nova Biomedical Corporation has at least 10 other 510(k) clearances on record.
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.