FDA applicant

Fujisawa Electronics Co.

Mchenry, IL1 decision1983–19830 recalls

FDA records 1 decision for Fujisawa Electronics Co. (Mchenry, IL) in 1983: 1 510(k) clearance. All are in product code GFK (Fibrinogen Determination Standards And Controls). 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, hematology panel, where it files most

How often FDA has decided Fujisawa Electronics Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fujisawa Electronics Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Fujisawa Electronics Co.’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

Fujisawa Electronics Co.

Which product codes does it file in?

What has FDA decided for it lately?