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510(k) K121445

TETRACHROME REAGENTS AND TETRACXP SYSTEM by Beckman Coulter, Inc. — Product Code OYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2013
Date Received
May 15, 2012
Clearance Type
Special
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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