K Number
K010665

Validate with FDA (Live)

Date Cleared
2001-04-27

(52 days)

Product Code
Regulation Number
890.5850
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