K Number
K251753Device Name
GenaCheck COVID-19 Rapid Self-TestManufacturer
Date Cleared
2025-09-05
(88 days)
Product Code
Regulation Number
866.3984Type
TraditionalPanel
MIReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A