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
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.