FDA 510(k) Applications for Medical Device Product Code "CFN"
(Method, Nephelometric, Immunoglobulins (G, A, M))

FDA 510(k) Number Applicant Device Name Decision Date
K781654 ANTIBODIES INC. NEPHELRATE ANTIPERUMS LGM 11/08/1978
K781655 ANTIBODIES INC. NEPHELRATE ANTISERUMS 1GA 11/08/1978
K781656 ANTIBODIES INC. NEPHELRATE ANTISERUMS, IGG 11/08/1978
K162208 BECKMAN COULTER INC. DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent 01/09/2017
K130122 BECKMAN COULTER, INC BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER 01/07/2014
K993549 BECKMAN COULTER, INC. BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR 02/01/2000
K993547 BECKMAN COULTER, INC. BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB 02/01/2000
K860894 BEHRING DIAGNOSTICS, INC. BEHRING NEPHELOMETER SYSTEM 04/15/1986
K880356 BEHRING DIAGNOSTICS, INC. N PROTEIN STANDARD PLASMA (HUMAN) 04/07/1988
K933971 CRESTAT DIAGNOSTICS, INC. N-ASSAY TIA IGA 03/22/1994
K933970 CRESTAT DIAGNOSTICS, INC. N-ASSAY TIA IGM 03/22/1994
K933973 CRESTAT DIAGNOSTICS, INC. N-ASSAY TIA MULTI V-NL 01/28/1994
K061338 DADE BEHRING, INC. DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY 07/06/2006
K061845 DADE BEHRING, INC. DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H 08/24/2006
K081161 DADE BEHRING, INC. DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST 07/28/2008
K073561 DADE BEHRING, INC. DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR 02/26/2008
K042735 DADE BEHRING, INC. N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) 02/15/2005
K032014 DADE BEHRING, INC. N LATEX IGM 08/07/2003
K864342 EIKEN CHEMICAL CO., INC. MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX 12/01/1986
K771226 HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES LAS-R TEST PROGRAM 07/21/1977
K871343 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM2/QM300 BUFFER AND DILUENT PACK 05/15/1987
K073489 OLYMPUS AMERICA INC. OLYMPUS IGA REAGENT 02/11/2008
K073490 OLYMPUS AMERICA INC. OLYMPUS IGG REAGENT 02/11/2008
K073487 OLYMPUS AMERICA INC. OLYMPUS IGM REAGENT 02/11/2008
K042475 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC 11/10/2004
K982382 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS INTEGRA REAGENT CASSETTES 09/28/1998
K090594 SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID 04/29/2009
K083445 SIEMENS HEALTHCARE DIAGNOSTICS N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC 03/24/2009
K042152 THE BINDING SITE BINDING SITE IGG SUBLCASS OLYMPUS KITS 11/22/2004
K103824 THE BINDING SITE HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS 02/27/2012
K082823 THE BINDING SITE GROUP LTD HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS 03/01/2010
K113823 THE BINDING SITE GROUP LTD HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT 03/27/2013
K100588 THE BINDING SITE GROUP LTD HUMAN IGA2 KIT FOR USE ON THE SPAPLUS 08/16/2010
K120749 THE BINDING SITE GROUP LTD HUMAN IGG CSF KIT 05/17/2013
K120750 THE BINDING SITE GROUP LTD HUMAN IGM CSF KIT 05/17/2013
K150526 THE BINDING SITE GROUP LTD Optilite IgG4 Kit 05/30/2015
K142735 THE BINDING SITE GROUP LTD The Optilite IgG3 kit 12/21/2014
K120901 THE BINDING SITE GROUP, LTD. HUMAN IGA CSF KIT FOR USE ON SPAPLUS 05/30/2013
K081827 THE BINDING SITE, LTD. HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS 12/19/2008
K981912 THE BINDING SITE, LTD. HUMAN IGA SUBCLASS BNII COMBI KIT 12/04/1998
K022083 THE BINDING SITE, LTD. HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER 07/16/2002
K000701 THE BINDING SITE, LTD. HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER 04/27/2000
K090920 THE BINDING SITE, LTD. HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) 12/30/2009
K072889 THE BINDING SITE, LTD. HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER 02/01/2008
K012296 THE BINDING SITE, LTD. HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T 08/31/2001
K012291 THE BINDING SITE, LTD. HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA 08/20/2001
K012292 THE BINDING SITE, LTD. HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB 08/31/2001
K012295 THE BINDING SITE, LTD. HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T 08/20/2001
K082129 THE BINDING SITE, LTD. HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER 02/10/2009
K982100 THE BINDING SITE, LTD. IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS 12/20/1999
K981784 THE BINDING SITE, LTD. IGM MININEPH ANTISERUM 12/21/1999
K923070 WAKO CHEMICALS, USA, INC. WAKO IGG-HA 08/20/1992
K993924 WAKO CHEMICALS, USA, INC. WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD 01/14/2000


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