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510(k) DEN220090

EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748) by Stemcell Technologies Canada, Inc. — Product Code QYO

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.