FDA Product Code LKP: Anti-sm Antibody, Antigen And Control
Leading manufacturers include Phadia AB.
28
Total
28
Cleared
99d
Avg days
1984
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Anti-sm Antibody, Antigen And Control Devices (Product Code LKP)
28 devices
About Product Code LKP - Regulatory Context
510(k) Submission Activity
28 total 510(k) submissions under product code LKP since 1984, with 28 receiving FDA clearance (average review time: 99 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
LKP devices are reviewed by the Immunology panel. Browse all Immunology devices →