FDA applicant

Bion Diagnostic Sciences

Redmond, WA1 decision2001–20010 recalls

FDA records 1 decision for Bion Diagnostic Sciences (Redmond, WA) in 2001: 1 510(k) clearance. All are in product code JHI (Visual, Pregnancy Hcg, Prescription Use). 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 Bion Diagnostic Sciences’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bion Diagnostic Sciences since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bion Diagnostic Sciences’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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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 Ent., Ltd. 14

Bion Diagnostic Sciences

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Bion”