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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name hematopoietic cell enrichment kit
De Novo Number DEN220090
Device Name EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)
Requester
stemcell technologies canada, inc.
1618 station st.
vancouver,  CA v6a 1b6
Contact jason peng
Regulation Number866.6120
Classification Product Code
QYO  
Date Received12/12/2022
Decision Date 11/06/2023
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Pathology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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