PTC · Class I · 21 CFR 862.1775

FDA Product Code PTC: Uric Acid Test System For At Home Prescription Use

For The Quantitative Measurement Of Uric Acid In Home Use Settings By Patients Diagnosed With Gout. This Device Is For Prescription Use Only.

Leading manufacturers include Apex BioTechnology Corp..

1
Total
1
Cleared
249d
Avg days
2025
Since

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

1 devices
1–1 of 1
Cleared Apr 04, 2025
UASure II Blood Uric Acid Monitoring System
K242209
Apex BioTechnology Corp.
Chemistry · 249d

How to use this database

This page lists all FDA 510(k) submissions for Uric Acid Test System For At Home Prescription Use devices (product code PTC). 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 →