K Number
K951517

Validate with FDA (Live)

Manufacturer
Date Cleared
1996-01-17

(289 days)

Product Code
Regulation Number
888.3353
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