510(k) Report

FDA applicant

Gamma Medical Products, Inc.

Mchenry, IL2 decisions1982–19840 recalls

FDA records 2 decisions for Gamma Medical Products, Inc. (Mchenry, IL) from 1982 to 1984: 2 510(k) clearances. All are in product code DAK (Complement C1q, Antigen, Antiserum, Control). 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Gamma Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Gamma”

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