DEN220090
- 510(k) number
- DEN220090
- Device name
- EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748)
- Applicant
- Stemcell Technologies Canada, Inc. CA
- Product code
- QYO — Hematopoietic Cell Enrichment Kit
- Decision date
- 2023-11-06
- Date received
- 2022-12-12
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Immunology
Official FDA record: DEN220090
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.