K Number
K951978Manufacturer
Date Cleared
1996-01-04
(252 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