FDA applicant

Icn Immunobiologicals

Lisle, IL2 decisions1988–19890 recalls

FDA records 2 decisions for Icn Immunobiologicals (Lisle, IL) from 1988 to 1989: 2 510(k) clearances. Most are in product codes DEW (Igg, Antigen, Antiserum, Control) and LKH (Antisera, Immunoperoxidase, Chlamydia Spp.). 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 Icn Immunobiologicals’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Icn Immunobiologicals since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Icn Immunobiologicals’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Icn Immunobiologicals

Which product codes does it file in?

What has FDA decided for it lately?