FDA applicant
Advanced Diagnostics, Inc.
FDA records 4 decisions for Advanced Diagnostics, Inc. (Preston, WA) from 2000 to 2003: 4 510(k) clearances. Most are in product codes NCS (System, Imaging, Holography, Acoustic) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). Its devices cite 3 predicates, 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
How often FDA has decided Advanced Diagnostics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Advanced Diagnostics, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Advanced 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