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510(k) K190294

CELL-DYN Emerald 22 AL System by Abbott Laboratories — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2019
Date Received
February 11, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Differential Cell
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

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