FDA applicant

Bion Ent., Ltd.

Park Ridge, IL14 decisions1980–19933 recalls

FDA records 14 decisions for Bion Ent., Ltd. (Park Ridge, IL) from 1980 to 1993: 14 510(k) clearances. Most are in product codes LKT (Respiratory Syncytial Virus, Antigen…) and DHN (Antinuclear Antibody, Indirect…). 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Bion Ent., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bion Ent., Ltd. since 2007.

Recalls per year

3in 2013

2007high 3 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Bion”

FDA records each applicant name separately; these may or may not be the same firm.

Bion Diagnostic Sciences 1

Bion Ent., Ltd.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Bion”