FDA applicant

Neogenex

Everett, WA20 decisions1994–19970 recalls

FDA records 20 decisions for Neogenex (Everett, WA) from 1994 to 1997: 20 510(k) clearances. Most are in product codes KIR (Cells, Animal And Human, Cultured) and GNW (Antisera, Cf, Influenza Virus A, B, C). 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 Neogenex’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Neogenex since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Neogenex

Which product codes does it file in?

What has FDA decided for it lately?