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 street |
vancouver,
CA
v6a 1b6
|
|
Contact |
jason peng |
|
Regulation Number | 866.6120
|
Classification Product Code |
|
Date Received | 12/12/2022 |
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
|
|
|