De Novo DEN220090
- Device
- EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)
- Contact
- jason peng
- De Novo number
- DEN220090
- Product code
- QYO
- Regulation
- 866.6120
- Classification name
- hematopoietic cell enrichment kit
- Decision
- granted (DENG)
- Decision date
- 2023-11-06
- Date received
- 2022-12-12
- Classification advisory
- Immunology
- Review advisory
- Pathology
- Type
- Direct
Current FDA Classification#
- Product code
- QYO
- Device name
- Hematopoietic Cell Enrichment Kit
- Medical specialty
- Immunology
- Device class
- 2
- Regulation
- 866.6120
- Implant
- N
- Life sustain/support
- N