FDA applicant

Koreamedico Co., Ltd.

Seoul, KR1 decision2007–20070 recalls

FDA records 1 decision for Koreamedico Co., Ltd. (Seoul, KR) in 2007: 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 Koreamedico Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Koreamedico Co., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?