510(k) Report

FDA applicant

Windsor Laboratories, Inc.

Garland, TX19 decisions1981–19870 recalls

FDA records 19 decisions for Windsor Laboratories, Inc. (Garland, TX) from 1981 to 1987: 19 510(k) clearances. Most are in product codes JIS (Calibrator, Primary) and DLJ (Calibrators, Drug Specific). 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 Windsor Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Windsor”

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