FDA applicant

Denka Seiken Co., Ltd.

Gosen-Shi, Niigata, JP6 decisions2003–20171 recall

FDA records 6 decisions for Denka Seiken Co., Ltd. (Gosen-Shi, Niigata, JP) from 2003 to 2017: 6 510(k) clearances. Most are in product codes JIT (Calibrator, Secondary) and JIS (Calibrator, Primary). Its devices cite 5 predicates, 0 of them its own earlier devices. 1 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 Denka Seiken Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2009

2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Other applicant names beginning “Denka”

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

Denka Seiken'S 4

Denka Seiken 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?

What has been recalled?

Other applicant names beginning “Denka”