De Novo DEN150059
- Device
- APAS Compact with Urine Analysis Module
- Contact
- lusia guthrie
- De Novo number
- DEN150059
- Product code
- PPU
- Regulation
- 866.2190
- Classification name
- microbial colony image assessment system
- Decision
- granted (DENG)
- Decision date
- 2016-10-06
- Date received
- 2015-12-24
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- PPU
- Device name
- Microbial Colony Image Assessment System
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.2190
- Implant
- N
- Life sustain/support
- N