FDA Product Code MOJ: Fluorescence Polarization Immunoassay, Diphenylhydantoin (free)
Leading manufacturers include Roche Diagnostics, Abbott Laboratories and Roche Diagnostic Systems, Inc..
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
Cleared
Mar 30, 2023
ONLINE TDM Phenytoin - Free Phenytoin application
Roche Diagnostics
Chemistry
69d
Cleared
Jul 31, 1995
COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS
Roche Diagnostic Systems, Inc.
Chemistry
59d
Cleared
May 02, 1995
TDX(R)/TDXFLX(R) FREE PHENYTOIN II
Abbott Laboratories
Toxicology
98d
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.