K Number
K010851
Date Cleared
2001-09-18

(181 days)

Product Code
Regulation Number
N/A
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

N/A