FDA applicant

Harleco

Mchenry, IL116 decisions1976–19820 recalls

FDA records 116 decisions for Harleco (Mchenry, IL) from 1976 to 1982: 116 510(k) clearances. Most are in product codes CGX (Alkaline Picrate, Colorimetry, Creatinine) and CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes). 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’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Harleco since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Harleco’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Harleco”

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

Harleco Diagnostics 23

Harleco

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Harleco”