K Number
DEN230085Manufacturer
Date Cleared
2024-11-12
(330 days)
Product Code
Regulation Number
880.6930Type
DirectPanel
HOReference & 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