FDA applicant

Immunogenetics

Mchenry, IL1 decision1982–19820 recalls

FDA records 1 decision for Immunogenetics (Mchenry, IL) in 1982: 1 510(k) clearance. All are in product code KRY (Calibrator For Platelet Counting). 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 Immunogenetics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Immunogenetics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Immunogenetics

Which product codes does it file in?

What has FDA decided for it lately?