FDA applicant

Labsystems, Inc.

Morton Grove, IL17 decisions1984–19930 recalls

FDA records 17 decisions for Labsystems, Inc. (Morton Grove, IL) from 1984 to 1993: 17 510(k) clearances. Most are in product codes LFX (Enzyme Linked Immunoabsorbent Assay, Rubella) and LGD (Enzyme Linked Immunoabsorbent Assay…). 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, microbiology panel, where it files most

How often FDA has decided Labsystems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Labsystems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Labsystems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?