De Novo DEN200059

Device: POMC/PCSK1/LEPR CDx Panel
Contact: jerry machado
De Novo number: DEN200059
Product code: QRV
Regulation: 862.1164
Classification name: setmelanotide eligibility gene variant detection system
Decision: granted (DENG)
Decision date: 2022-01-21
Date received: 2020-09-18
Classification advisory: Clinical Chemistry
Review advisory: Clinical Chemistry
Type: Direct

Current FDA Classification#

Product code: QRV
Device name: Setmelanotide Eligibility Gene Variant Detection System
Medical specialty: Clinical Chemistry
Device class: 2
Regulation: 862.1164
Implant: N
Life sustain/support: N