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510(k) K183205

PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System by Emcyte Corporation — Product Code JQC

Clearance Details

Decision
SESU ()
Decision Date
May 30, 2019
Date Received
November 19, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

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