FDA applicant

Infopia Co, Ltd.

Great Neck, NY20 decisions2005–20160 recalls

FDA records 20 decisions for Infopia Co, Ltd. (Great Neck, NY) from 2005 to 2016: 20 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and LCP (Assay, Glycosylated Hemoglobin). Its devices cite 26 predicates, 14 of them its own earlier devices. 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 Infopia Co, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007high 4 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Infopia Co, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?