Quest Diagnostics Incorporated is one of 13027 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Quest Diagnostics Incorporated - FDA 510(k) Cleared Devices
Recent clearances: Quest Diagnostics HairCheck-DT (Cocaine)
Quest Diagnostics Incorporated, is a major clinical laboratory and diagnostic testing company. The company operates with a manufacturing facility in Lenexa, Kansas. Quest provides comprehensive laboratory testing services to patients and healthcare professionals nationwide.
Quest has received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory focus centers on Toxicology devices. The clearance was granted in 2016. No submissions have been cleared since that time, making this a historical regulatory record for the company.
The cleared device, Quest Diagnostics HairCheck-DT (Cocaine), represents the company's work in substance detection and toxicology testing. This reflects Quest's broader expertise in clinical drug monitoring and diagnostic analysis for healthcare providers and patients.
Explore the device name, product code, and clearance date in the full regulatory record above.