EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)
FDA 510(k) clearance DEN220090 · decided 2023-11-06
Clearance details
- K-number
- DEN220090
- Device name
- EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)
- Applicant
- Stemcell Technologies Canada, Inc.
- Decision
- Unknown
- Date received
- 2022-12-12
- Decision date
- 2023-11-06
- Days to decision
- 329 days
- Clearance type
- Direct
- Product code
- QYO
- Device class
- 2
- Regulation number
- 866.6120
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Vancouver, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.