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510(k) K183205

Device
PureBMC SupraPhysiologic Concentrating System 30 ML System, PureBMC SupraPhysiologic Concentrating System 60 ML System, PureBMC SupraPhysiologic Concentrating System 120 ML System
Applicant
EmCyte Corporation
510(k) number
K183205
Product code
JQC  
Decision
Se - With Limitations (SESU)
Decision date
2019-05-30
Date received
2018-11-19
Regulation
862.2050
Classification name
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
Medical specialty
Clinical Chemistry
Review panel
Hematology
Device class
1
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Patrick Pennie
Address
4331 Veronica S. Shoemaker Blvd., Suite 4 Fort Meyers FL US 33916 33916

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JQC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K103340SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEMHarvest Technologies, Corp.2010-12-06
K081345AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)Thermogenesis Corp.2008-07-10
K071934MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KITBiomet Manufacturing Corp2007-10-11
K070666GENESISCS COMPONENT CONCENTRATING SYSTEMPerfusion Partners & Assoc., Inc.2007-06-20
K052925SMARTPREP2 CENTRIFUGE SYSTEMHarvest Technologies, Corp.2006-01-04
K042473COBE ANGEL WHOLE BLOOD SEPARATION SYSTEMCobe Cardiovascular, Inc.2004-11-19
K024080SECQUIRE CELL SEPARATORPerfusion Partners & Assoc., Inc.2003-07-02
K030340AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)Cytomedix2003-04-11
K030555GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-ABiomet, Inc.2003-04-11
K021902MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300Medtronic Vascular2002-08-12
K9941483I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEMImplant Innovations, Inc.2000-02-01
K991430SMARTPREP CENTRIFUGE SYSTEMHarvest Technologies, LLC1999-05-28
K944738SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGEDucker CL1994-10-19
K881254STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01Norfolk Scientific, Inc.1988-04-05
K864974GENERAL PURPOSE CENTRIFUGENorfolk Scientific, Inc.1987-01-09

Legacy Summary#

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FDA Review#

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