FDA applicant

Gamma Enterprises, Inc.

Mchenry, IL23 decisions1977–19790 recalls

FDA records 23 decisions for Gamma Enterprises, Inc. (Mchenry, IL) from 1977 to 1979: 23 510(k) clearances. Most are in product codes CIG (Diazo Colorimetry, Bilirubin) and CDH (Acid, Uric, Phosphotungstate Reduction). 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 Gamma Enterprises, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gamma Enterprises, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Gamma”

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

Gamma Biologicals, Inc. 21 Gamma Medica-Ideas Incorporated 2 Gamma Medical Products, Inc. 2 Gamma Medica 1

Gamma Enterprises, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Gamma”