510(k) Report

FDA applicant

Labone, Inc.

Lenexa, KS2 decisions2004–20040 recalls

FDA records 2 decisions for Labone, Inc. (Lenexa, KS) in 2004: 2 510(k) clearances. Most are in product codes DIO (Enzyme Immunoassay, Cocaine And Cocaine…) and DLJ (Calibrators, Drug Specific). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 toxicology panel, where it files most

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

FDA decisions per year

No FDA decision for Labone, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Labone, 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?

  • DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites1decision
  • DLJCalibrators, Drug Specific1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K033601Labone Micro-Plate Cotinine EiaLabone, Inc. · 20041cites it

What has FDA decided for it lately?

  • K040198Labone Cocaine Metabolite Micro-Plate EiaLabone, Inc. · 2004
  • K033601Labone Micro-Plate Cotinine EiaLabone, Inc. · 2004

All 2 as Labone, Inc. →