K251281
- 510(k) number
- K251281
- Device name
- Nova Max Creat eGFR Monitoring System
- Applicant
- Nova Biomedical Corporation MA · US
- Product code
- SHB — Creatinine Test System For At Home Prescription Use
- Decision date
- 2026-01-21
- Date received
- 2025-04-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251281.pdf
Official FDA record: K251281
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.