510(k) K251281
- Device
- Nova Max Creat eGFR Monitoring System
- Applicant
- Nova Biomedical Corporation
- 510(k) number
- K251281
- Product code
- SHB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-21
- Date received
- 2025-04-24
- Regulation
- 862.1225
- Classification name
- Creatinine Test System For At Home Prescription Use
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Mariya Cesnulevicius
- Address
- 200 Prospect St. Walham MA US 02454 02454