De Novo DEN130011

Device
ILLUMINA MISEQDX PLATFORM
Contact
leanne m kiviharju
De Novo number
DEN130011
Product code
PFF
Regulation
862.2265
Classification name
high throughput dna sequence analyzer
Decision
granted (DENG)
Decision date
2013-11-19
Date received
2013-09-23
Classification advisory
Immunology
Review advisory
Clinical Chemistry
Type
Post-NSE

Current FDA Classification#

Product code
PFF
Device name
High Throughput Dna Sequence Analyzer
Medical specialty
Immunology
Device class
2
Regulation
862.2265
Implant
N
Life sustain/support
N