FDA applicant

Texas Intl. Laboratories, Inc.

Houston, TX10 decisions1983–19960 recalls

FDA records 10 decisions for Texas Intl. Laboratories, Inc. (Houston, TX) from 1983 to 1996: 10 510(k) clearances. Most are in product codes GKZ (Counter, Differential Cell) and GKL (Counter, Cell, Automated (Particle Counter)). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Texas Intl. Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Texas Intl. 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

Texas Intl. Laboratories, Inc.

Which product codes does it file in?

What has FDA decided for it lately?