K Number
DEN240047Device Name
Allix5Manufacturer
Date Cleared
2025-05-30
(266 days)
Product Code
Regulation Number
892.8500Type
DirectPanel
RAReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A