FDA applicant

Colony Laboratories, Inc.

Washington, DC16 decisions1989–19890 recalls

FDA records 16 decisions for Colony Laboratories, Inc. (Washington, DC) in 1989: 16 510(k) clearances. Most are in product codes DLJ (Calibrators, Drug Specific) and DLG (Coating, Liquid, Glc). 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, clinical toxicology panel, where it files most

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

FDA decisions per year

No FDA decision for Colony Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Colony 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

Colony Laboratories, Inc.

Which product codes does it file in?

What has FDA decided for it lately?