FDA applicant

Genmark Diagnostics, Incorporated

Carlsbad, CA8 decisions2011–20220 recalls

FDA records 8 decisions for Genmark Diagnostics, Incorporated (Carlsbad, CA) from 2011 to 2022: 8 510(k) clearances. Most are in product codes PEN (Gram-Negative Bacteria And Associated…) and NSU (Instrumentation For Clinical Multiplex Test…). Its devices cite 6 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “GenMark Diagnostics, Inc.”.

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 Genmark Diagnostics, Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2011high 2 (2017) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Genmark Diagnostics, Incorporated by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Genmark Diagnostics, Incorporated

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?