FDA applicant

Stat Engineering

Mchenry, IL1 decision1980–19800 recalls

FDA records 1 decision for Stat Engineering (Mchenry, IL) in 1980: 1 510(k) clearance. All are in product code KHM (Nephelometric, Amylase). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Stat Engineering since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Stat”

FDA records each applicant name separately; these may or may not be the same firm.

Stat Medical Devices 4 Stat Medical Corp. 4 Stat Path 4 Stat-Spin Technologies 1 Stat Chem, Inc. 1

Stat Engineering

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Stat”