K Number
K010738

Validate with FDA (Live)

Manufacturer
Date Cleared
2001-08-01

(142 days)

Product Code
Regulation Number
888.3040
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

Loading...

N/A