Scanadu, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Scanadu, Inc. - FDA 510(k) Cleared Devices
Recent clearances: inui In-Home Urine Analysis Test System
1
Total
1
Cleared
0
Denied
Scanadu, Inc. is a medical device company with a manufacturing facility in Sunnyvale, US. The company specialized in at-home diagnostic testing systems.
Scanadu received 1 FDA 510(k) clearance from 1 total submission. The company focused exclusively on Chemistry devices. The clearance was granted in 2018. Scanadu is now inactive, with no new FDA submissions in over five years, and should be treated as a historical regulatory record.
The company's cleared device was the inui In-Home Urine Analysis Test System, a Chemistry-based diagnostic tool designed for consumer use. This product represented Scanadu's core focus on accessible, at-home clinical testing.
Explore the company's FDA 510(k) clearance history, device names, and submission dates in the regulatory database.
FDA 510(k) Regulatory Record - Scanadu, Inc.
1 devices