FDA applicant

Alerchek, Inc.

Portland, ME3 decisions1986–19890 recalls

FDA records 3 decisions for Alerchek, Inc. (Portland, ME) from 1986 to 1989: 3 510(k) clearances. Most are in product codes DHB (System, Test, Radioallergosorbent (Rast)…) and DGC (Ige, 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 Alerchek, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Alerchek, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Alerchek, Inc.

Which product codes does it file in?

What has FDA decided for it lately?