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 |
| K162208 | BECKMAN COULTER INC. | DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent | 01/09/2017 |
| K221114 | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Immunoglobulin G (IgG) | 08/02/2023 |
| 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 |
| 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 |
| 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 |
| K192116 | The Binding Site Group Ltd | Human IgA liquid reagent kit for Use on SPAPlus | 09/04/2019 |
| 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 |
| K191465 | The Binding Site Group Ltd. | Human IgM Kit for use on SPAPlus | 06/27/2019 |
| K183151 | The Binding Site Group Ltd. | Optilite IgA CSF Kit | 01/23/2019 |
| K191985 | The Binding Site Group Ltd. | Optilite IgA Kit | 08/19/2019 |
| K190686 | The Binding Site Group Ltd. | Optilite IgM CSF Kit | 05/28/2019 |
| K191635 | The Binding Site Group Ltd. | Optilite IgM Kit | 07/15/2019 |
| 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 |
| K993924 | WAKO CHEMICALS, USA, INC. | WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD | 01/14/2000 |
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