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 |
| K113480 | CARIDIANBCT, INC. | SPECTRA OPTIA APHERESIS SYSTEM | 01/20/2012 |
| K103090 | CARIDIANBCT, INC. | SPECTRA OPTIA R APHERESIS SYSTEM | 11/19/2010 |
| 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 |
| K192150 | Fresenius Kabi AG | AMICUS Separator System | 11/13/2019 |
| K180615 | Fresenius Kabi USA LLC | AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter | 12/04/2018 |
| 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 |
| 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 |
| K953681 | HAEMONETICS CORP. | HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET | 06/04/1996 |
| 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 |
| K181049 | Terumo BCT, Inc. | Spectra Optia Apheresis System | 11/01/2018 |
| K183081 | Terumo BCT, Inc. | Spectra Optia Apheresis System | 02/05/2019 |
| 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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