FDA applicant

Tudor Laboratories, Inc.

Dallas, TX9 decisions1989–19920 recalls

FDA records 9 decisions for Tudor Laboratories, Inc. (Dallas, TX) from 1989 to 1992: 9 510(k) clearances. Most are in product codes DLJ (Calibrators, Drug Specific) and LFM (Enzyme Immunoassay, Digitoxin). 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 Tudor Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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Tudor Laboratories, Inc.

Which product codes does it file in?

What has FDA decided for it lately?