Nova Max Creat eGFR Monitoring System
FDA 510(k) K251281 · Nova Biomedical Corporation
510(k) numberK251281
Submission
- Device name
- Nova Max Creat eGFR Monitoring System
- Applicant
- Nova Biomedical Corporation
Walham, MA, US - Received
- April 24, 2025
- Decision date
- January 21, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SHB – Creatinine Test System For At Home Prescription Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1225
- Specialty
- Clinical Chemistry
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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Questions and answers
When was Nova Max Creat eGFR Monitoring System cleared by the FDA?
Nova Max Creat eGFR Monitoring System (K251281) received a 510(k) decision of Substantially Equivalent on January 21, 2026, 272 days after the submission was received.
What is the product code of K251281?
The FDA product code is SHB – Creatinine Test System For At Home Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1225.