K Number
K003185Device Name
FS ACTIVATOR IIIManufacturer
Date Cleared
2001-03-20
(160 days)
Product Code
Regulation Number
N/AType
TraditionalPanel
PMReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A