510(k) Report

FDA applicant

Earl-Clay Laboratories, Inc.

Mchenry, IL21 decisions1984–19860 recalls

FDA records 21 decisions for Earl-Clay Laboratories, Inc. (Mchenry, IL) from 1984 to 1986: 21 510(k) clearances. Most are in product codes KIR (Cells, Animal And Human, Cultured) and KIT (Media And Components, Synthetic Cell And…). 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 Earl-Clay Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Earl-Clay Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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