De Novo DEN040003

Device: GLUCATELL
Contact: stacy suberg
De Novo number: DEN040003
Product code: NQZ
Regulation: 866.3050
Classification name: antigen, invasive fungal pathogens
Decision: granted (DENG)
Decision date: 2004-05-21
Date received: 2004-03-22
Classification advisory: Microbiology
Review advisory: Microbiology
Type: Post-NSE

Current FDA Classification#

Product code: NQZ
Device name: Antigen, Invasive Fungal Pathogens
Medical specialty: Microbiology
Device class: 2
Regulation: 866.3050
Implant: N
Life sustain/support: N