FDA applicant

Affymetrix, Inc.

Santa Clara, CA3 decisions2008–20140 recalls

FDA records 3 decisions for Affymetrix, Inc. (Santa Clara, CA) from 2008 to 2014: 2 510(k) clearances and 1 De Novo grant. Most are in product codes PFX (System, Microarray-Based, Genome-Wide…) and NSU (Instrumentation For Clinical Multiplex Test…). Its devices cite 1 predicate, 1 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 chemistry panel, where it files most

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

FDA decisions per year

1in 2014

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Affymetrix, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Affymetrix, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?