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LKN — Separator, Automated, Blood Cell And Plasma, Therapeutic Class U

FDA Device Classification

Classification Details

Product Code
LKN
Device Class
Class U
Regulation Number
Submission Type
Review Panel
GU
Medical Specialty
Unknown
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K192150fresenius kabiAMICUS Separator SystemNovember 13, 2019
K183081terumobctSpectra Optia Apheresis SystemFebruary 5, 2019
K180615fresenius kabi usaAMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set,December 4, 2018
K181049terumobctSpectra Optia Apheresis SystemNovember 1, 2018
K172590terumobctSpectra Optia Apheresis SystemMarch 2, 2018
K153601terumobctSpectra Optia Apheresis SystemJanuary 14, 2016
K151368terumo bctSpectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection),September 11, 2015
K141938terumobctSPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBMarch 23, 2015
K141019fenwalAMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHEDJune 10, 2014
K132429terumobctSPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCDecember 6, 2013
K131744terumobctSPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OAugust 8, 2013
K111702fenwalAMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMarch 22, 2012
K113480caridianbctSPECTRA OPTIA APHERESIS SYSTEMJanuary 20, 2012
K103090caridianbctSPECTRA OPTIA R APHERESIS SYSTEMNovember 19, 2010
K071079gambro bctSPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200August 2, 2007
K060734fresenius medical care north americaFRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, CSeptember 5, 2006
K050273fresenius medical care north americaFRESENIUS ART HEMOADSORPTION SYSTEMJune 8, 2005
K961706fresenius usaP1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELLJuly 31, 1996
K953681haemoneticsHAEMONETICS THERAPEUTIC PLASMA EXCHANGE SETJune 4, 1996
K926409apheresis technologiesPLASMA DISCARD BAGSMarch 2, 1993