K Number
K010721

Validate with FDA (Live)

Date Cleared
2001-03-30

(18 days)

Product Code
Regulation Number
892.1600
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

Loading...

N/A