K Number
K002596Device Name
GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09Manufacturer
Date Cleared
2001-02-15
(178 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