K Number
DEN240035Device Name
ConcizuTrace ELISAManufacturer
Date Cleared
2025-05-22
(325 days)
Product Code
Regulation Number
864.7298Type
DirectPanel
HEReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A