FDA applicant

Bio Focus Co., Lt.

Gardena, CA1 decision2006–20060 recalls

FDA records 1 decision for Bio Focus Co., Lt. (Gardena, CA) in 2006: 1 510(k) clearance. All are in product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). 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 Focus Co., Lt.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio Focus Co., Lt. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Bio Focus Co., Lt.

Which product codes does it file in?

What has FDA decided for it lately?