K Number
K001323Manufacturer
Date Cleared
2000-07-25
(90 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