FDA Product Code KXT: Enzyme Immunoassay, Digoxin
Leading manufacturers include Siemens Healthcare Diagnostics, Inc..
85
Total
85
Cleared
86d
Avg days
1979
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Enzyme Immunoassay, Digoxin Devices (Product Code KXT)
85 devices
About Product Code KXT - Regulatory Context
510(k) Submission Activity
85 total 510(k) submissions under product code KXT since 1979, with 85 receiving FDA clearance (average review time: 86 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
KXT devices are reviewed by the Toxicology panel. Browse all Toxicology devices →