FDA Product Code NWM: Immunoassay, Anti-seizure Drug
To Aid In Management Of Patients Treated With Anti-seizure Drug.
Leading manufacturers include ARK Diagnostics, Inc..
5
Total
5
Cleared
203d
Avg days
2005
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Immunoassay, Anti-seizure Drug Devices (Product Code NWM)
5 devices
About Product Code NWM - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code NWM since 2005, with 5 receiving FDA clearance (average review time: 203 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
NWM devices are reviewed by the Toxicology panel. Browse all Toxicology devices →