FDA applicant

Gamma Biologicals, Inc.

Mchenry, IL21 decisions1976–19860 recalls

FDA records 21 decisions for Gamma Biologicals, Inc. (Mchenry, IL) from 1976 to 1986: 21 510(k) clearances. Most are in product codes KSX (Substance, Blood Grouping Of Non-Human Origin…) and KHE (Reagent, Occult Blood). 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, hematology panel, where it files most

How often FDA has decided Gamma Biologicals, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Gamma Biologicals, Inc.’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 “Gamma”

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

Gamma Enterprises, Inc. 23 Gamma Medica-Ideas Incorporated 2 Gamma Medical Products, Inc. 2 Gamma Medica 1

Gamma Biologicals, 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?

Other applicant names beginning “Gamma”