Quest Diagnostics, Inc. - FDA 510(k) Cleared Devices

Quest Diagnostics, Inc. is a leading clinical laboratory services company with a manufacturing facility in Las Vegas, Nevada. The company specializes in diagnostic testing and laboratory analysis for patients and healthcare providers.

Quest Diagnostics received 7 FDA 510(k) clearances from 7 total submissions between 2003 and 2008. The company's regulatory portfolio is dominated by Toxicology devices, which account for 86% of submissions. This historical record reflects the company's focus on substance abuse and drug screening technologies.

The company's cleared devices include microplate enzyme immunoassay systems and hair-based drug detection products targeting amphetamines, cocaine, PCP, THC, and opiates. These Toxicology platforms supported clinical drug monitoring and workplace testing applications.

Quest Diagnostics has not received FDA 510(k) clearances since 2008 and is no longer active in the regulatory submission process. This profile serves as a historical record of the company's medical device regulatory activity. Explore the complete device clearance history, product codes, and submission dates in the database.