FDA Product Code LKJ: Antinuclear Antibody, Antigen, Control
Leading manufacturers include Phadia AB.
50
Total
50
Cleared
88d
Avg days
1983
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Antinuclear Antibody, Antigen, Control Devices (Product Code LKJ)
50 devices
About Product Code LKJ - Regulatory Context
510(k) Submission Activity
50 total 510(k) submissions under product code LKJ since 1983, with 50 receiving FDA clearance (average review time: 88 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
LKJ devices are reviewed by the Immunology panel. Browse all Immunology devices →