Astute Medical, Inc. is one of 14060 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Astute Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: NEPHROCHECK Test System, NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit
3
Total
2
Cleared
1
Denied
Astute Medical, Inc. has 2 FDA 510(k) cleared medical devices. Based in San Diego, US.
Historical record: 2 cleared submissions from 2014 to 2017. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Astute Medical, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Hogan Lovells US LLP as regulatory consultant.
FDA 510(k) Regulatory Record - Astute Medical, Inc.
3 devices