FDA applicant
Windsor Laboratories, Inc.
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
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.
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.
See the 510(k) ReportOther applicant names beginning “Windsor”
FDA records each applicant name separately; these may or may not be the same firm.