510(k) Report

FDA applicant

Tech America Diagnostics

San Marcos, CA3 decisions1984–19850 recalls

FDA records 3 decisions for Tech America Diagnostics (San Marcos, CA) from 1984 to 1985: 3 510(k) clearances. Most are in product codes DHN (Antinuclear Antibody, Indirect…) and DBM (Antimitochondrial Antibody, Indirect…). 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 Tech America Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tech America Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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