FDA Product Code MMW: System, Test, Tumor Marker, Monitoring, Bladder
Leading manufacturers include Nucleix , Ltd..
9
Total
9
Cleared
251d
Avg days
1997
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared System, Test, Tumor Marker, Monitoring, Bladder Devices (Product Code MMW)
9 devices
About Product Code MMW - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code MMW since 1997, with 9 receiving FDA clearance (average review time: 251 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
MMW devices are reviewed by the Medical Genetics panel. Browse all Medical Genetics devices →