FDA Product Code LOJ: Kit, Test,alpha-fetoprotein For Testicular Cancer
Leading manufacturers include Ortho-Clinical Diagnostics and Roche Diagnostics.
17
Total
17
Cleared
135d
Avg days
1985
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Kit, Test,alpha-fetoprotein For Testicular Cancer Devices (Product Code LOJ)
17 devices
Cleared
Sep 15, 2022
Elecsys AFP
Roche Diagnostics
Immunology
237d
Cleared
Jun 15, 2022
VITROS AFP
Ortho-Clinical Diagnostics
Immunology
210d
About Product Code LOJ - Regulatory Context
510(k) Submission Activity
17 total 510(k) submissions under product code LOJ since 1985, with 17 receiving FDA clearance (average review time: 135 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
LOJ devices are reviewed by the Immunology panel. Browse all Immunology devices →