FDA applicant

Bio-Reagents & Diagnostics, Inc.

Mchenry, IL4 decisions1976–19780 recalls

FDA records 4 decisions for Bio-Reagents & Diagnostics, Inc. (Mchenry, IL) from 1976 to 1978: 4 510(k) clearances. Most are in product codes JIX (Calibrator, Multi-Analyte Mixture) and LAS (Drug Specific 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 Bio-Reagents & Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio-Reagents & Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Bio-Reagents & Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?