FDA 510(k) Applications for Medical Device Product Code "LKN"
(Separator, Automated, Blood Cell And Plasma, Therapeutic)

FDA 510(k) Number Applicant Device Name Decision Date
K926409 APHERESIS TECHNOLOGIES, INC. PLASMA DISCARD BAGS 03/02/1993
K113480 CARIDIANBCT, INC. SPECTRA OPTIA APHERESIS SYSTEM 01/20/2012
K103090 CARIDIANBCT, INC. SPECTRA OPTIA R APHERESIS SYSTEM 11/19/2010
K893962 COBE LABORATORIES, INC. COBE 2991 SUPPLEMENTARY DISPOSABLE SETS 10/18/1989
K900105 COBE LABORATORIES, INC. COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC 03/22/1991
K830831 CRYOSAN, INC. AUTOMATED BLOOD CELL SEPARATOR 06/16/1983
K111702 FENWAL, INC. AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE 03/22/2012
K141019 FENWAL, INC. AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED 06/10/2014
K050273 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS ART HEMOADSORPTION SYSTEM 06/08/2005
K060734 FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE) 09/05/2006
K895435 FRESENIUS USA, INC. FRESENIUS AS 104 CELL SEPARATOR 11/02/1990
K961706 FRESENIUS USA, INC. P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR 07/31/1996
K071079 GAMBRO BCT, INC. SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 08/02/2007
K850621 GAMBRO, INC. GAMBRO PLASMAFILTRATION SYSTEM 05/16/1985
K953681 HAEMONETICS CORP. HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET 06/04/1996
K831004 INTL. BUSINESS MACHINES AUTOMATED 8400 BLOOD CELL SEPARATOR 09/12/1983
K874607 ORGANON TEKNIKA CORP. FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS 01/27/1988
K151368 TERUMO BCT Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter 09/11/2015
K153601 Terumo BCT, Inc Spectra Optia Apheresis System 01/14/2016
K172590 Terumo BCT, Inc. Spectra Optia Apheresis System 03/02/2018
K141938 TERUMO BCT, INC.. SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET) 03/23/2015
K131744 TERUMO BCT, INC.. SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE 08/08/2013
K132429 TERUMO BCT, INC.. SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET 12/06/2013


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