K Number
DEN240038Device Name
Oxiplex®Manufacturer
Date Cleared
2025-06-17
(330 days)
Product Code
Regulation Number
888.3047Type
DirectPanel
ORReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A