510(k) Report

FDA applicant

Zetek, Inc.

Chicago, IL1 decision1985–19850 recalls

FDA records 1 decision for Zetek, Inc. (Chicago, IL) in 1985: 1 510(k) clearance. All are in product code NGE (Test, Luteinizing Hormone (Lh), Over The Counter). 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 Zetek, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zetek, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Zetek, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NGETest, Luteinizing Hormone (Lh), Over The Counter1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K850579Cue Fertility MonitorZetek, Inc. · 19851cites it

What has FDA decided for it lately?

  • K850579Cue Fertility MonitorZetek, Inc. · 1985

The one decision as Zetek, Inc. →