510(k) Report

FDA applicant

Zbx Corporation

Toronto, CA1 decision2004–20040 recalls

FDA records 1 decision for Zbx Corporation (Toronto, CA) in 2004: 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 Zbx Corporation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zbx Corporation since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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