De Novo DEN240032

Device: APO-Easy Genotyping kit
Contact: huseyin firat
De Novo number: DEN240032
Product code: SFC
Regulation: 866.5850
Classification name: neurologic disease risk assessment molecular test
Decision: granted (DENG)
Decision date: 2025-06-12
Date received: 2024-06-21
Classification advisory: Immunology
Review advisory: Immunology
Type: Direct

Current FDA Classification#

Product code: SFC
Device name: Neurologic Disease Risk Assessment Molecular Test
Medical specialty: Immunology
Device class: 2
Regulation: 866.5850
Implant: N
Life sustain/support: N