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