FDA applicant

Hi Chem, Inc.

Mchenry, IL52 decisions1977–19960 recalls

FDA records 52 decisions for Hi Chem, Inc. (Mchenry, IL) from 1977 to 1996: 52 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and CGA (Glucose Oxidase, Glucose). 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 Hi Chem, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hi Chem, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Hi Chem, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?