510(k) DEN200052
- Device
- KidneyIntelX.dkd
- Applicant
- Renalytix Ai, Inc.
- 510(k) number
- DEN200052
- Product code
- QWZ
- Decision
- Unknown (DENG)
- Decision date
- 2023-06-29
- Date received
- 2020-08-26
- Regulation
- 862.1223
- Classification name
- Prognostic Test For Assessment Of Chronic Kidney Disease Progression
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Joe Hutson
- Address
- 1460 Broadway New York NY US 10036 10036
FDA Registration Numbers#
- 3018739912
Source Documents#
510(k) summary PDF not indicated by FDA