K Number
K010047
Date Cleared
2001-05-29

(144 days)

Product Code
Regulation Number
N/A
Panel
TX
Reference & 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