De Novo DEN170019
- Device
- Vitamin D 200M Assay for the Topaz System
- Contact
- shilpa sharma
- De Novo number
- DEN170019
- Product code
- PSL
- Regulation
- 862.1840
- Classification name
- 25-oh-vitamin d mass spectrometry test system
- Decision
- granted (DENG)
- Decision date
- 2017-05-18
- Date received
- 2017-03-20
- Classification advisory
- Clinical Chemistry
- Review advisory
- Clinical Chemistry
- Type
- Post-NSE
Current FDA Classification#
- Product code
- PSL
- Device name
- 25-Oh-Vitamin D Mass Spectrometry Test System
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation
- 862.1840
- Implant
- N
- Life sustain/support
- N