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CFN — Method, Nephelometric, Immunoglobulins (G, A, M) Class II

FDA Device Classification

Classification Details

Product Code
CFN
Device Class
Class II
Regulation Number
866.5510
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233663siemens healthcare diagnostics productsN Antisera to Human Immunoglobulins (IgG, IgA, and IgM)December 13, 2023
K221114beckman coulter laboratory systems (suzhou) coImmunoglobulin G (IgG)August 2, 2023
K192116binding site groupHuman IgA liquid reagent kit for Use on SPAPlusSeptember 4, 2019
K191985binding site groupOptilite IgA KitAugust 19, 2019
K191635binding site groupOptilite IgM KitJuly 15, 2019
K191465binding site groupHuman IgM Kit for use on SPAPlusJune 27, 2019
K190686binding site groupOptilite IgM CSF KitMay 28, 2019
K183151binding site groupOptilite IgA CSF KitJanuary 23, 2019
K162208beckman coulterDxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentJanuary 9, 2017
K150526binding site groupOptilite IgG4 KitMay 30, 2015
K142735binding site groupThe Optilite IgG3 kitDecember 21, 2014
K130122beckman coulterBECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, January 7, 2014
K120901binding site groupHUMAN IGA CSF KIT FOR USE ON SPAPLUSMay 30, 2013
K120750binding site groupHUMAN IGM CSF KITMay 17, 2013
K120749binding site groupHUMAN IGG CSF KITMay 17, 2013
K113823binding site groupHEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KITMarch 27, 2013
K103824binding siteHUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUSFebruary 27, 2012
K100588binding site groupHUMAN IGA2 KIT FOR USE ON THE SPAPLUSAugust 16, 2010
K082823binding site groupHEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITSMarch 1, 2010
K090920binding siteHUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODDecember 30, 2009