FDA applicant
Texas Immunology, Inc.
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
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.
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.
See the 510(k) Report