SHB · Class II · 21 CFR 862.1225

FDA Product Code SHB: Creatinine Test System For At Home Prescription Use

For The Quantitative Measurement Of Creatinine In Home Use Settings By Patients As An Aid To Monitor Kidney Function. This Device Is For Prescription Use Only.

Leading manufacturers include Nova Biomedical Corporation.

1
Total
1
Cleared
272d
Avg days
2026
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Creatinine Test System For At Home Prescription Use Devices (Product Code SHB)

1 devices
1–1 of 1
Cleared Jan 21, 2026
Nova Max Creat eGFR Monitoring System
K251281
Nova Biomedical Corporation
Chemistry · 272d

About Product Code SHB - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SHB since 2026, with 1 receiving FDA clearance (average review time: 272 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SHB devices are reviewed by the Chemistry panel. Browse all Chemistry devices →