510(k) Report

FDA applicant

Diadexus, Inc.

South San Francisco, CA7 decisions2003–201410 recalls

FDA records 7 decisions for Diadexus, Inc. (South San Francisco, CA) from 2003 to 2014: 7 510(k) clearances. All are in product code NOE (Test, System, Immunoassay…). Its devices cite 5 predicates, 4 of them its own earlier devices. 10 recalls are 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 Diadexus, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007: 12011: 12014: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2010

2008: 22009: 72010: 1
2007high 7 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Diadexus, 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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