FDA applicant

Biodiagnostic Intl

Mchenry, IL11 decisions1983–20040 recalls

FDA records 11 decisions for Biodiagnostic Intl (Mchenry, IL) from 1983 to 2004: 11 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and DIF (Drug Mixture Control Materials). 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, clinical chemistry panel, where it files most

How often FDA has decided Biodiagnostic Intl’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biodiagnostic Intl since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Biodiagnostic Intl

Which product codes does it file in?

What has FDA decided for it lately?