FDA Product Code MOJ: Fluorescence Polarization Immunoassay, Diphenylhydantoin (free)
Leading manufacturers include Roche Diagnostics.
3
Total
3
Cleared
75d
Avg days
1995
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Fluorescence Polarization Immunoassay, Diphenylhydantoin (free) Devices (Product Code MOJ)
3 devices
About Product Code MOJ - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code MOJ since 1995, with 3 receiving FDA clearance (average review time: 75 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
MOJ devices are reviewed by the Chemistry panel. Browse all Chemistry devices →