FDA Product Code LJX: Test, Urine Leukocyte
Leading manufacturers include Healgen Scientific, LLC.
7
Total
7
Cleared
94d
Avg days
1985
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Test, Urine Leukocyte Devices (Product Code LJX)
7 devices
About Product Code LJX - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code LJX since 1985, with 7 receiving FDA clearance (average review time: 94 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
LJX devices are reviewed by the Chemistry panel. Browse all Chemistry devices →