DFH — Kappa, Antigen, Antiserum, Control Class II

FDA Device Classification

Classification Details

Product Code
DFH
Device Class
Class II
Regulation Number
866.5550
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253358diazyme laboratoriesDiazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free LiDecember 19, 2025
K250549binding site groupOptilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitMay 23, 2025
K231601sebiaFLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2February 23, 2024
K231290binding siteOptilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitJanuary 24, 2024
K210623sebiaFLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2November 18, 2022
K211648diazyme laboratoriesDiazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light ChaiSeptember 8, 2022
K220001diazyme laboratoriesDiazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light ChaiAugust 4, 2022
K212379siemens healthcare diagnostics productsN Latex FLC kappa, N Latex FLC lambdaMarch 2, 2022
K201496siemens healthcare diagnostics productsN Latex FLC kappa, N Latex FLC lambdaOctober 29, 2021
K193047siemens healthcare diagnostics productsN Latex FLC kappa, N Latex FLC lambdaJuly 14, 2021
K190879siemens healthcare diagnostics productsN Latex FLC kappa, N Latex FLC lambdaMay 3, 2019
K182098siemens healthcare diagnostics productsN Latex FLC kappa assay, N Latex FLC lambda assayNovember 1, 2018
K173732binding site groupOptilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free KitAugust 23, 2018
K181438diazyme laboratoriesDiazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light ChaiJune 26, 2018
K171742siemens healthcare diagnostics productsN Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC ContNovember 17, 2017
K153394diazyme laboratoriesDiazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light ChaiNovember 18, 2016
K150658binding site groupOptilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free KitAugust 26, 2015
K120056binding site groupHUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSERApril 1, 2013
K083602sentinel chKAPPA LIGHT CHAINSSeptember 3, 2009
K082503siemens healthcare diagnosticsDIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYDecember 19, 2008