FDA applicant
Nowdiagnostics
FDA records 1 decision for Nowdiagnostics (Springdale, AZ) in 2024: 1 De Novo grant. All are in product code SBZ (Test For Detection Of Antibodies Associated…). 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 Nowdiagnostics’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2024high 1 (2024) · low 0 (2025)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Nowdiagnostics’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