510(k) Report

FDA applicant

Amatech International, Inc.

Houston, TX3 decisions1986–19880 recalls

FDA records 3 decisions for Amatech International, Inc. (Houston, TX) from 1986 to 1988: 3 510(k) clearances. Most are in product codes JJB (Azo-Dyes, Colorimetric, Bilirubin & Its…) and GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Amatech International, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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