510(k) K210793
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 2022
- Date Received
- March 16, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acute Kidney Injury Test System
- Device Class
- Class II
- Regulation Number
- 862.1220
- Review Panel
- CH
- Submission Type
An acute kidney injury test system is intended to measure one or more analytes in human samples as an aid in the assessment of a patient's risk for developing acute kidney injury. Test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including conifmration by alternative methods.