FDA Product Code JGS: Electrode, Ion Specific, Sodium
Leading manufacturers include Abbott Laboratories, Siemens Healthcare Diagnostics, Inc. and Abbott Point of Care, Inc..
FDA 510(k) Cleared Electrode, Ion Specific, Sodium Devices (Product Code JGS)
About Product Code JGS - Regulatory Context
510(k) Submission Activity
162 total 510(k) submissions under product code JGS since 1977, with 162 receiving FDA clearance (average review time: 95 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under JGS have taken an average of 267 days to reach a decision - up from 94 days historically. Manufacturers should account for longer review timelines in current project planning.
JGS devices are reviewed by the Chemistry panel. Browse all Chemistry devices →