K Number
K962854Manufacturer
Date Cleared
1997-01-27
(189 days)
Product Code
Regulation Number
N/AType
TraditionalPanel
CVReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A