510(k) DEN180030
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 19, 2018
- Date Received
- June 25, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plazomicin Test System, Immunoassay
- Device Class
- Class II
- Regulation Number
- 862.3460
- Review Panel
- TX
- Submission Type
A plazomicin test system is a device intended to measure plazomicin in human specimens. Measurements obtained by this device are used in monitoring levels of plazomicin to ensure appropriate therapy in patients with complicated urinary tract infection.