FDA applicant

Helmer Labs, Inc.

Mchenry, IL3 decisions1977–19810 recalls

FDA records 3 decisions for Helmer Labs, Inc. (Mchenry, IL) from 1977 to 1981: 3 510(k) clearances. Most are in product codes KSQ (Device, Blood Mixing And Blood Weighing) and GLE (Mixer, Blood Tube). 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 Helmer Labs, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Helmer Labs, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Helmer Labs, Inc.

Which product codes does it file in?

What has FDA decided for it lately?