FDA applicant
Xtrana, Inc.
FDA records 1 decision for Xtrana, Inc. (Ventura, CA) in 2002: 1 510(k) clearance. All are in product code DAP (Fibrinogen And Fibrin Split Products, Antigen…). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Xtrana, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Xtrana, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Xtrana, 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