FDA applicant

Denka Seiken'S

Tokyo, JP4 decisions1998–20020 recalls

FDA records 4 decisions for Denka Seiken'S (Tokyo, JP) from 1998 to 2002: 4 510(k) clearances. Most are in product codes MYI (System, Test, Genotypic Detection, Resistant…) and DCN (System, Test, C-Reactive Protein). Its devices cite 1 predicate, 0 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, microbiology panel, where it files most

How often FDA has decided Denka Seiken'S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Denka Seiken'S since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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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 Co., Ltd. 6

Denka Seiken'S

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?

Other applicant names beginning “Denka”