Skip to content
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