510(k) DEN130031
DEN130031 is an FDA 510(k) premarket notification submitted by Astute Medical, Inc. for the device "NEPHROCHECK TEST SYSTEM". The FDA issued a decision of De Novo Granted on September 5, 2014. The device falls under product code PIG (Acute Kidney Injury Test System), a Class II device regulated under 21 CFR 862.1220. Astute Medical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 5, 2014
- Date Received
- June 5, 2013
- Clearance Type
- Direct
- 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.