K Number
K963001

Validate with FDA (Live)

Date Cleared
1997-03-11

(221 days)

Product Code
Regulation Number
886.5925
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