FDA applicant

Harleco Diagnostics

Mchenry, IL23 decisions1976–19820 recalls

FDA records 23 decisions for Harleco Diagnostics (Mchenry, IL) from 1976 to 1982: 23 510(k) clearances. Most are in product codes CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes) and CIX (Bromcresol Green Dye-Binding, Albumin). 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 Harleco Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Harleco Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Harleco”

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

Harleco 116

Harleco Diagnostics

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Harleco”