K Number
K132046

Validate with FDA (Live)

Date Cleared
2013-09-23

(83 days)

Product Code
Regulation Number
888.3560
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