K Number
K010047Manufacturer
Date Cleared
2001-05-29
(144 days)
Product Code
Regulation Number
N/AType
TraditionalPanel
TXReference & 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