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510(k) K193124

Unicel DxH 800 Coulter Cellular Analysis System by Beckman Coulter — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2020
Date Received
November 12, 2019
Clearance Type
Traditional
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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