FDA applicant

Immunotech Corp.

Boston, MA42 decisions1980–20190 recalls

FDA records 42 decisions for Immunotech Corp. (Boston, MA) from 1980 to 2019: 42 510(k) clearances. Most are in product codes GKZ (Counter, Differential Cell) and CDP (Radioimmunoassay, Total Triiodothyronine). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Immunotech, Inc.”, “Immunotech S.A.”, “Immunotech S.R.O.”.

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 Immunotech Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007high 1 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Immunotech Corp.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?