SHB · Creatinine Test System For At Home Prescription Use
Clinical Chemistry · 21 CFR 862.1225 · Class 2
Overview
| Product Code | SHB |
|---|---|
| Device Name | Creatinine Test System For At Home Prescription Use |
| Regulation | 21 CFR 862.1225 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251281 | Nova Max Creat eGFR Monitoring System | Nova Biomedical Corporation | Jan 21, 2026 | SESE |
Top Applicants
- Nova Biomedical Corporation — 1 clearance
