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510(k) BK190317

Device
Platelet Separation/Concentration System
Applicant
EmCyte Corporation
510(k) number
BK190317
Product code
JQC  
Decision
Substantially Equivalent (SE)
Decision date
2020-02-12
Date received
2019-02-11
Regulation
862.2050
Classification name
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Clearance type
510(k) Traditio
Third party reviewed
No

Other 510(k) Records For Product Code JQC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K183205PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL SystemEmcyte Corporation2019-05-30
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

Legacy Summary#

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FDA Review#

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