FDA applicant
Diadexus, Inc.
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
How often FDA has decided Diadexus, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2007high 1 (2007) · low 0 (2008)2026
2026 so far, outlined.
Recalls per year
1in 2010
2007high 7 (2009) · low 0 (2007)2026
Class I Class II/III not classified
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.
See the 510(k) Report