K Number
K251320Device Name
XTRA4Manufacturer
Date Cleared
2025-09-11
(135 days)
Product Code
Regulation Number
N/AType
TraditionalPanel
OPReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A