510(k) Report

FDA applicant

Biologics Intl., Inc.

Mchenry, IL9 decisions1979–19880 recalls

FDA records 9 decisions for Biologics Intl., Inc. (Mchenry, IL) from 1979 to 1988: 9 510(k) clearances. Most are in product codes JHJ (Agglutination Method, Human Chorionic…) and DCN (System, Test, C-Reactive Protein). 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 Biologics Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biologics Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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