510(k) DEN220090
- Device
- EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)
- Applicant
- Stemcell Technologies Canada, Inc.
- 510(k) number
- DEN220090
- Product code
- QYO
- Decision
- Unknown (DENG)
- Decision date
- 2023-11-06
- Date received
- 2022-12-12
- Regulation
- 866.6120
- Classification name
- Hematopoietic Cell Enrichment Kit
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jason Peng
- Address
- 1618 Station St. Vancouver CA V6A 1B6 V6A 1B6
FDA Registration Numbers#
- 3004450619
Source Documents#
510(k) summary PDF not indicated by FDA