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EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)

DEN220090 Class II Direct
Decision Date
2023-11-06
Sponsor / Applicant
Stemcell Technologies Canada, Inc.

Technical Specification

510(k) Submission ID DEN220090
Product Code QYO
Medical Specialty / Panel Immunology
Regulation Citation 21 CFR 866.6120
Decision Date 2023-11-06
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748) received FDA 510(k) clearance under submission number DEN220090, sponsored by Stemcell Technologies Canada, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2023-11-06.

Classification & Regulation

This clearance is catalogued under FDA product code QYO and 21 CFR 866.6120, within the Immunology review panel as a Class II device.