FDA applicant

Fairleigh Dickinson Laboratories, Inc.

Abilene, TX7 decisions1985–19900 recalls

FDA records 7 decisions for Fairleigh Dickinson Laboratories, Inc. (Abilene, TX) from 1985 to 1990: 7 510(k) clearances. Most are in product codes LJC (Enzyme Linked Immunoabsorbent Assay…) and KZJ (Device, Gas Generating). No recall is linked to its devices.

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

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Fairleigh Dickinson Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fairleigh Dickinson Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Fairleigh Dickinson Laboratories, 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

Fairleigh Dickinson Laboratories, Inc.

Which product codes does it file in?

What has FDA decided for it lately?