K Number
DEN230085
Manufacturer
Date Cleared
2024-11-12

(330 days)

Product Code
Regulation Number
880.6930
Type
Direct
Panel
HO
Reference & 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