KidneyIntelX.dkd
FDA 510(k) clearance DEN200052 · decided 2023-06-29
Clearance details
- K-number
- DEN200052
- Device name
- KidneyIntelX.dkd
- Applicant
- Renalytix Ai, Inc.
- Decision
- Unknown
- Date received
- 2020-08-26
- Decision date
- 2023-06-29
- Days to decision
- 1037 days
- Clearance type
- Direct
- Product code
- QWZ
- Device class
- 2
- Regulation number
- 862.1223
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.