510(k) Report

FDA applicant

Texas Immunology, Inc.

Tyler, TX27 decisions1982–19990 recalls

FDA records 27 decisions for Texas Immunology, Inc. (Tyler, TX) from 1982 to 1999: 27 510(k) clearances. Most are in product codes JHJ (Agglutination Method, Human Chorionic…) and DHR (System, Test, Rheumatoid Factor). 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Texas Immunology, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Texas Immunology, 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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