FDA applicant

Kyoto Daiichi Kagaku Co., Ltd.

Kyoto, 601, JP3 decisions1982–19880 recalls

FDA records 3 decisions for Kyoto Daiichi Kagaku Co., Ltd. (Kyoto, 601, JP) from 1982 to 1988: 3 510(k) clearances. Most are in product codes KQO (Automated Urinalysis System) and LFR (Glucose Dehydrogenase, Glucose). 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 Kyoto Daiichi Kagaku Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kyoto Daiichi Kagaku Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kyoto Daiichi Kagaku 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 “Kyoto”

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

Kyoto Diagnostics, Inc. 11

Kyoto Daiichi Kagaku Co., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Kyoto”