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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
510(k) Number K183205
Device Name PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
Applicant
Emcyte Corporation
4331 Veronica S. Shoemaker Blvd., Suite 4
Fort Meyers,  FL  33916
Applicant Contact Patrick Pennie
Correspondent
Emcyte Corporation
4331 Veronica S. Shoemaker Blvd., Suite 4
Fort Meyers,  FL  33916
Correspondent Contact Patrick Pennie
Regulation Number862.2050
Classification Product Code
JQC  
Subsequent Product Code
FMF  
Date Received11/19/2018
Decision Date 05/30/2019
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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