510(k) DEN180030
DEN180030 is an FDA 510(k) premarket notification submitted by Microgenics Corporation for the device "QMS Plazomicin Immunoassay". The FDA issued a decision of De Novo Granted on November 19, 2018. The device falls under product code QDR (Plazomicin Test System, Immunoassay), a Class II device regulated under 21 CFR 862.3460. Microgenics Corporation has at least 10 other 510(k) clearances on record.
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.