De Novo DEN180030
- Device
- QMS Plazomicin Immunoassay
- Contact
- minoti patel
- De Novo number
- DEN180030
- Product code
- QDR
- Regulation
- 862.3460
- Classification name
- plazomicin test system, immunoassay
- Decision
- granted (DENG)
- Decision date
- 2018-11-19
- Date received
- 2018-06-25
- Classification advisory
- Toxicology
- Review advisory
- Toxicology
- Type
- Direct
Current FDA Classification#
- Product code
- QDR
- Device name
- Plazomicin Test System, Immunoassay
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation
- 862.3460
- Implant
- N
- Life sustain/support
- N