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De Novo DEN200052
- Device
- KidneyIntelX.dkd
- Contact
- joe hutson
- De Novo number
- DEN200052
- Product code
- QWZ
- Regulation
- 862.1223
- Classification name
- prognostic test for assessment of chronic kidney disease progression
- Decision
- granted (DENG)
- Decision date
- 2023-06-29
- Date received
- 2020-08-26
- Classification advisory
- Clinical Chemistry
- Review advisory
- Clinical Chemistry
- Type
- Direct
Current FDA Classification#
- Product code
- QWZ
- Device name
- Prognostic Test For Assessment Of Chronic Kidney Disease Progression
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation
- 862.1223
- Implant
- N
- Life sustain/support
- N