FDA applicant

Kyoto Diagnostics, Inc.

Mchenry, IL11 decisions1984–19860 recalls

FDA records 11 decisions for Kyoto Diagnostics, Inc. (Mchenry, IL) from 1984 to 1986: 11 510(k) clearances. Most are in product codes JIL (Method, Enzymatic, Glucose (Urinary…) and JMT (Diazo (Colorimetric), Nitrite (Urinary…). 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 Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kyoto Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kyoto Diagnostics, Inc.’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 “Kyoto”

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

Kyoto Daiichi Kagaku Co., Ltd. 3

Kyoto Diagnostics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Kyoto”