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510(k) K232600

DxFLEX Flow Cytometer; ClearLLab 10C Panels by Beckman Coulter, Inc. — Product Code OYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2023
Date Received
August 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flow Cytometric Reagents And Accessories.
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer.

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