510(k) DEN220090
DEN220090 is an FDA 510(k) premarket notification submitted by Stemcell Technologies Canada, Inc. for the device "EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748)". The FDA issued a decision of De Novo Granted on November 6, 2023. The device falls under product code QYO (Hematopoietic Cell Enrichment Kit), a Class II device regulated under 21 CFR 866.6120.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 6, 2023
- Date Received
- December 12, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hematopoietic Cell Enrichment Kit
- Device Class
- Class II
- Regulation Number
- 866.6120
- Review Panel
- MG
- Submission Type
A hematopoietic cell enrichment kit is an in vitro diagnostic device intended for the selection and enrichment of specific hematopoietic cells from human whole blood and/or bone marrow collected from patients with hematological malignancies using immunomagnetic bead-based selection. It is intended for use with diagnostic assays as part of the pre-analytical workflow.