FDA applicant

Dutchland Laboratories, Inc.

Mchenry, IL75 decisions1981–19820 recalls

FDA records 75 decisions for Dutchland Laboratories, Inc. (Mchenry, IL) from 1981 to 1982: 75 510(k) clearances. Most are in product codes KIT (Media And Components, Synthetic Cell And…) and KIS (Sera, Animal And Human). 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 Dutchland Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dutchland Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dutchland Laboratories, Inc.’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

Dutchland Laboratories, Inc.

Which product codes does it file in?

What has FDA decided for it lately?