FDA Product Code CEM: Electrode, Ion Specific, Potassium
Leading manufacturers include Randox Laboratories, Ltd. and Roche Diagnostics.
2
Total
2
Cleared
136d
Avg days
2023
Since
List of Electrode, Ion Specific, Potassium devices cleared through 510(k)
2 devices
Cleared
Feb 12, 2026
ISE indirect K for Gen.2
Roche Diagnostics
Chemistry
111d
Cleared
Sep 08, 2023
ISE Electrodes
Randox Laboratories, Ltd.
Chemistry
161d
How to use this database
This page lists all FDA 510(k) submissions for Electrode, Ion Specific, Potassium devices (product code CEM). 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 →