K Number
K961013

Validate with FDA (Live)

Date Cleared
1996-12-20

(282 days)

Product Code
Regulation Number
890.1385
Age Range
N/A
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

Loading...

N/A