FDA applicant

Immco Diagnostics, Inc.

Buffalo, NY55 decisions1988–20180 recalls

FDA records 55 decisions for Immco Diagnostics, Inc. (Buffalo, NY) from 1988 to 2018: 55 510(k) clearances. Most are in product codes LLL (Extractable Antinuclear Antibody, Antigen And…) and MVM (Autoantibodies, Endomysial (Tissue…). 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 Immco Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2007high 6 (2010) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Immco Diagnostics, 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?