FDA applicant

Quest Diagnostics, Inc.

Las Vegas, NV8 decisions2003–20160 recalls

FDA records 8 decisions for Quest Diagnostics, Inc. (Las Vegas, NV) from 2003 to 2016: 8 510(k) clearances. Most are in product codes DIO (Enzyme Immunoassay, Cocaine And Cocaine…) and DKZ (Enzyme Immunoassay, Amphetamine). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Quest Diagnostics Incorporated”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical toxicology panel, where it files most

How often FDA has decided Quest Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Quest Diagnostics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Quest Diagnostics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Quest”

FDA records each applicant name separately; these may or may not be the same firm.

Quest Medical, Inc. 39 Quest Intl., Inc. 25 Quest International, Inc. 3 Quest Dental USA Corp. 2 Quest Medical Imaging 2 Quest Diagnostics Nichols Institute 1 Quest Technologies Corp. 1 Quest Enabling Designs, Ltd. 1

Quest Diagnostics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Quest”