De Novo DEN140039
- Device
- NOVA View Automated Fluorescense Microscope
- Contact
- gabriella lakos
- De Novo number
- DEN140039
- Product code
- PIV
- Regulation
- 866.4750
- Classification name
- automated indirect immunofluorescence microscope and software-assisted system for clinical use
- Decision
- granted (DENG)
- Decision date
- 2015-04-09
- Date received
- 2014-12-15
- Classification advisory
- Immunology
- Review advisory
- Immunology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- PIV
- Device name
- Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
- Medical specialty
- Immunology
- Device class
- 2
- Regulation
- 866.4750
- Implant
- N
- Life sustain/support
- N