EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748)— 510(k) DEN220090

Name: FDA 510(k) clearance DEN220090
Creator: U.S. Food and Drug Administration
Published: 2023-11-06

Unknown

Stemcell Technologies Canada, Inc.

FDA 510(k) clearance DEN220090 for EasySep Human Bone Marrow CD138 Positive Selection Kit (100-0748), Unknown on 2023-11-06. Applicant: Stemcell Technologies Canada, Inc.. Device class: 2.

Clearance details

Applicant: Stemcell Technologies Canada, Inc.
Product code: Code QYO
Device class: Class 2
Regulation: 21 CFR 866.6120
Advisory panel: Immunology
Date received: 2022-12-12
Decision date: 2023-11-06
Decision: Unknown
Clearance type: Direct
Location: Vancouver, CA

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