FDA applicant

Diagnostics Biochem Canada, Inc.

Mchenry, IL6 decisions1978–20030 recalls

FDA records 6 decisions for Diagnostics Biochem Canada, Inc. (Mchenry, IL) from 1978 to 2003: 6 510(k) clearances. Most are in product codes CDZ (Radioimmunoassay, Testosterones And…) and CIZ (Radioimmunoassay, Androstenedione). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Diagnostics Biochem Canada, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Diagnostics Biochem Canada, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Diagnostics Biochem Canada, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?