K Number
K003824Manufacturer
Date Cleared
2001-03-08
(87 days)
Product Code
Regulation Number
N/AType
TraditionalPanel
SUReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A