K Number
DEN240021
Date Cleared
2025-04-09

(328 days)

Product Code
Regulation Number
890.3780
Type
Direct
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

N/A