510(k) Report

FDA applicant

Great Lakes Intl.

Mchenry, IL1 decision1984–19840 recalls

FDA records 1 decision for Great Lakes Intl. (Mchenry, IL) in 1984: 1 510(k) clearance. All are in product code JTW (System, Transport, Aerobic). 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, microbiology panel, where it files most

How often FDA has decided Great Lakes Intl.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Great Lakes Intl. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • JTWSystem, Transport, Aerobic1decision

What has FDA decided for it lately?

  • K840719Bakteriette-VI-PakGreat Lakes Intl. · 1984

The one decision as Great Lakes Intl. →

Other applicant names beginning “Great”

FDA records each applicant name separately; these may or may not be the same firm.

Great Lakes Orthodontics, Ltd. 13Great Batch Medical 11Great Glove Sdn Bhd 4Great Basin Scientific, Inc. 4Great Glove (China), Inc. 2Great Eastern Lumber Co., Inc. 2Great Glove (Thailand) Co., Ltd. 2Great Field Industries Co., Ltd. 1Great Eco Glove Sdn. Bhd. 1Great Future Works, Ltd. 1Great West Medical Equipment, Inc. 1Great Bay Medical Products, Inc. 1