De Novo DEN190035

Device: Helix Laboratory Platform
Contact: gloria lee
De Novo number: DEN190035
Product code: QNC
Regulation: 866.6000
Classification name: whole exome sequencing constituent device
Decision: granted (DENG)
Decision date: 2020-12-23
Date received: 2019-08-02
Classification advisory: Molecular Genetics
Review advisory: Molecular Genetics
Type: Direct

Current FDA Classification#

Product code: QNC
Device name: Whole Exome Sequencing Constituent Device
Medical specialty: Medical Genetics
Device class: 2
Regulation: 866.6000
Implant: N
Life sustain/support: N