510(k) Report

FDA applicant

Lab-Interlink, Inc.

Omaha, NE1 decision2001–20010 recalls

FDA records 1 decision for Lab-Interlink, Inc. (Omaha, NE) in 2001: 1 510(k) clearance. All are in product code JJE (Analyzer, Chemistry (Photometric, Discrete)…). 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 Lab-Interlink, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lab-Interlink, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use1decision

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.

  • K010500Automated Workcell Control SoftwareLab-Interlink, Inc. · 20011cites it

What has FDA decided for it lately?

  • K010500Automated Workcell Control SoftwareLab-Interlink, Inc. · 2001

The one decision as Lab-Interlink, Inc. →