K Number
K120520

Validate with FDA (Live)

Manufacturer
Date Cleared
2012-06-29

(129 days)

Product Code
Regulation Number
892.5770
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