FDA applicant

Gelco Diagnostics, Inc.

Mchenry, IL14 decisions1983–19830 recalls

FDA records 14 decisions for Gelco Diagnostics, Inc. (Mchenry, IL) in 1983: 14 510(k) clearances. Most are in product codes DFH (Kappa, Antigen, Antiserum, Control) and DEW (Igg, Antigen, Antiserum, Control). 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 Gelco Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gelco Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Gelco Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?