K Number
DEN240064Device Name
CT-132Manufacturer
Date Cleared
2025-04-11
(150 days)
Product Code
Regulation Number
882.5806Type
DirectPanel
NEReference & 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