FDA applicant
Xenotope Diagnostics, Inc.
FDA records 1 decision for Xenotope Diagnostics, Inc. (Northridge, CA) in 2003: 1 510(k) clearance. All are in product code JWZ (Kit, Screening, Trichomonas). 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 Xenotope Diagnostics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Xenotope Diagnostics, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Xenotope Diagnostics, 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