K Number
K000519Device Name
GLUCANPROManufacturer
Date Cleared
2000-05-01
(75 days)
Product Code
Regulation Number
N/AType
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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N/A