FDA Product Code CEM: Electrode, Ion Specific, Potassium
Leading manufacturers include Radiometer Medicals Aps, Roche Diagnostics and Randox Laboratories, Ltd..
FDA 510(k) Cleared Electrode, Ion Specific, Potassium Devices (Product Code CEM)
About Product Code CEM - Regulatory Context
510(k) Submission Activity
89 total 510(k) submissions under product code CEM since 1977, with 89 receiving FDA clearance (average review time: 90 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under CEM have taken an average of 192 days to reach a decision - up from 88 days historically. Manufacturers should account for longer review timelines in current project planning.
CEM devices are reviewed by the Chemistry panel. Browse all Chemistry devices →