K Number
DEN240032Device Name
APO-Easy Genotyping kitManufacturer
Date Cleared
2025-06-12
(356 days)
Product Code
Regulation Number
866.5850Type
DirectPanel
ImmunologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A