510(k) Report

FDA applicant

Genova Diagnostics

Asheville, NC1 decision2006–20060 recalls

FDA records 1 decision for Genova Diagnostics (Asheville, NC) in 2006: 1 De Novo grant. All are in product code NXO (Calprotectin, Fecal). 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, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Genova Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Genova Diagnostics 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?

  • NXOCalprotectin, Fecal1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • DEN060001Phical TestGenova Diagnostics · 20062cite it

What has FDA decided for it lately?

  • DEN060001Phical TestGenova Diagnostics · 2006

The one decision as Genova Diagnostics →