De Novo DEN240080

Device: Biolinq Shine Autonomous Time-in-Range Microsensor
Contact: kate hunter
De Novo number: DEN240080
Product code: SFU
Regulation: 862.1359
Classification name: glucose range monitoring system
Decision: granted (DENG)
Decision date: 2025-09-23
Date received: 2024-12-27
Classification advisory: Clinical Chemistry
Review advisory: Clinical Chemistry
Type: Direct

Current FDA Classification#

Product code: SFU
Device name: Glucose Range Monitoring System
Medical specialty: Clinical Chemistry
Device class: 2
Regulation: 862.1359
Implant: N
Life sustain/support: N