510(k) Report

FDA applicant

Labtronix Corp.

Mchenry, IL2 decisions1981–19810 recalls

FDA records 2 decisions for Labtronix Corp. (Mchenry, IL) in 1981: 2 510(k) clearances. Most are in product codes GKL (Counter, Cell, Automated (Particle Counter)) and GLG (Platelet Counting, Manual). 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 Labtronix Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Labtronix Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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