FDA applicant

Eiken Chemical Co., Ltd.

Taito-Ku, JP4 decisions1985–20200 recalls

FDA records 4 decisions for Eiken Chemical Co., Ltd. (Taito-Ku, JP) from 1985 to 2020: 4 510(k) clearances. Most are in product codes KHE (Reagent, Occult Blood) and OOX (Automated Occult Blood Analyzer). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Eiken Chemical Co., Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Eiken Chemical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Eiken”

FDA records each applicant name separately; these may or may not be the same firm.

Eiken Kizai Co., Ltd. 1

Eiken Chemical Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Eiken”