510(k) K251281 ยท SHB Creatinine Test System For At Home Prescription Use
Nova Max Creat eGFR Monitoring System
| Applicant | Nova Biomedical Corporation, Walham MA, US |
| Decision | Substantially Equivalent, Jan 21, 2026 |
| Received | Apr 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251281
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.