FDA applicant

Gen-Probe Prodesse, Inc.

Waukesha, WI10 decisions2010–20130 recalls

FDA records 10 decisions for Gen-Probe Prodesse, Inc. (Waukesha, WI) from 2010 to 2013: 10 510(k) clearances. Most are in product codes OCC (Respiratory Virus Panel Nucleic Acid Assay…) and OQW (2009 H1n1 Influenza Virus (Swine Origin)…). Its devices cite 27 predicates, 4 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, microbiology panel, where it files most

How often FDA has decided Gen-Probe Prodesse, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

7in 2013

2010high 7 (2013) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Gen-Probe Prodesse, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Gen-Probe Prodesse, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?