K Number
K011001Manufacturer
Date Cleared
2001-06-07
(90 days)
Product Code
Regulation Number
N/AType
TraditionalPanel
DEReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A