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

List of Creatinine Test System For At Home Prescription Use devices cleared through 510(k)

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

How to use this database

This page lists all FDA 510(k) submissions for Creatinine Test System For At Home Prescription Use devices (product code SHB). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Chemistry FDA review panel. Browse all Chemistry devices →