510(k) Report

FDA applicant

Thyroid Diagnostics, Inc.

Mchenry, IL2 decisions1981–19850 recalls

FDA records 2 decisions for Thyroid Diagnostics, Inc. (Mchenry, IL) from 1981 to 1985: 2 510(k) clearances. Most are in product codes JQF (Bathophenanthroline, Iron Binding Capacity) and LCP (Assay, Glycosylated Hemoglobin). 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 Thyroid Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Thyroid Diagnostics, Inc. 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?

  • JQFBathophenanthroline, Iron Binding Capacity1decision
  • LCPAssay, Glycosylated Hemoglobin1decision

What has FDA decided for it lately?

  • K852111Glyco-CheckThyroid Diagnostics, Inc. · 1985
  • K811942J & S Iron Saturating ReagentThyroid Diagnostics, Inc. · 1981

All 2 as Thyroid Diagnostics, Inc. →