K Number
K961223Manufacturer
Date Cleared
1996-12-10
(256 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