De Novo DEN180007
- Device
- Miris Human Milk Analyzer
- Contact
- elin hallen
- De Novo number
- DEN180007
- Product code
- QEI
- Regulation
- 862.1493
- Classification name
- breast milk macronutrients test system
- Decision
- granted (DENG)
- Decision date
- 2018-12-21
- Date received
- 2018-02-12
- Classification advisory
- Clinical Chemistry
- Review advisory
- Clinical Chemistry
- Type
- Direct
Current FDA Classification#
- Product code
- QEI
- Device name
- Breast Milk Macronutrients Test System
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation
- 862.1493
- Implant
- N
- Life sustain/support
- N