K Number
K011001
Manufacturer
Date Cleared
2001-06-07

(90 days)

Product Code
Regulation Number
N/A
Panel
DE
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