FDA Product Code
FDA Product Code SHB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1225
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251281 | Nova Max Creat eGFR Monitoring System | Nova Biomedical Corporation | 2026-01-21 | Traditional | PDF ↗ |
Product code SHB · Class II · Clinical Chemistry. Data: openFDA.