K Number
K960363Manufacturer
Date Cleared
1997-02-18
(390 days)
Product Code
Regulation Number
N/AType
TraditionalPanel
ORReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A