ClearanceBrief
Panels › Immunology › Product code CFN · Class 2

Method, Nephelometric, Immunoglobulins (G, A, M)

Regulation 866.5510

0510(k)s in 12 months (61 all time)
0recalls in 12 months (20 all time)
18recalls that name a 510(k)
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Top companies in CFN

Company510(k)sRecalls
The Binding Site Group , Ltd.1411
The Binding Site150
Beckman Coulter, Inc.44
Dade Behring, Inc.60
Siemens Healthcare Diagnostics24
Antibodies, Inc.30
Crestat Diagnostics, Inc.30
Olympus America, Inc.30
Behring Diagnostics, Inc.20
Wako Chemicals USA, Inc.20
Decided510(k)Device and applicantCode
Dec 13, 2023K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
Siemens Healthcare Diagnostics Products GmbH, DE
CFN
Aug 2, 2023K221114Immunoglobulin G (IgG)
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd., CN
CFN
Sep 4, 2019K192116Human IgA liquid reagent kit for Use on SPAPlus
The Binding Site Group , Ltd., GB
CFN
Aug 19, 2019K191985Optilite IgA Kit
The Binding Site Group , Ltd., GB
CFN
Jul 15, 2019K191635Optilite IgM Kit
The Binding Site Group , Ltd., GB
CFN
Jun 27, 2019K191465Human IgM Kit for use on SPAPlus
The Binding Site Group , Ltd., GB
CFN
May 28, 2019K190686Optilite IgM CSF Kit
The Binding Site Group , Ltd., GB
CFN
Jan 23, 2019K183151Optilite IgA CSF Kit
The Binding Site Group , Ltd., GB
CFN
Jan 9, 2017K162208DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
Beckman Coulter, Inc.
CFN
May 30, 2015K150526Optilite IgG4 Kit
The Binding Site Group , Ltd., GB
CFN
Dec 21, 2014K142735The Optilite IgG3 kit
The Binding Site Group , Ltd., GB
CFN
Jan 7, 2014K130122BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
Beckman Coulter, Inc.
CFN
May 30, 2013K120901HUMAN IGA CSF KIT FOR USE ON SPAPLUS
The Binding Site Group , Ltd., GB
CFN
May 17, 2013K120750HUMAN IGM CSF KIT
The Binding Site Group , Ltd., GB
CFN
May 17, 2013K120749HUMAN IGG CSF KIT
The Binding Site Group , Ltd., GB
CFN
Mar 27, 2013K113823HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT
The Binding Site Group , Ltd., GB
CFN
Feb 27, 2012K103824HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS
The Binding Site, GB
CFN
Aug 16, 2010K100588HUMAN IGA2 KIT FOR USE ON THE SPAPLUS
The Binding Site Group , Ltd.
CFN
Mar 1, 2010K082823HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS
The Binding Site Group , Ltd.
CFN
Dec 30, 2009K090920HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
The Binding Site, Ltd.
CFN
Apr 29, 2009K090594DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID
Siemens Healthcare Diagnostics
CFN
Mar 24, 2009K083445N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC
Siemens Healthcare Diagnostics
CFN
Feb 10, 2009K082129HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
The Binding Site, Ltd.
CFN
Dec 19, 2008K081827HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
The Binding Site, Ltd.
CFN
Jul 28, 2008K081161DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST
Dade Behring, Inc.
CFN
Feb 26, 2008K073561DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR
Dade Behring, Inc.
CFN
Feb 11, 2008K073490OLYMPUS IGG REAGENT
Olympus America, Inc., IE
CFN
Feb 11, 2008K073489OLYMPUS IGA REAGENT
Olympus America, Inc., IE
CFN
Feb 11, 2008K073487OLYMPUS IGM REAGENT
Olympus America, Inc., IE
CFN
Feb 1, 2008K072889HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
The Binding Site, Ltd.
CFN
Aug 24, 2006K061845DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H
Dade Behring, Inc.
CFN
Jul 6, 2006K061338DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY
Dade Behring, Inc.
CFN
Feb 15, 2005K042735N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
Dade Behring, Inc.
CFN
Nov 22, 2004K042152BINDING SITE IGG SUBLCASS OLYMPUS KITS
The Binding Site
CFN
Nov 10, 2004K042475VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC
Ortho-Clinical Diagnostics, Inc.
CFN
Aug 7, 2003K032014N LATEX IGM
Dade Behring, Inc.
CFN
Jul 16, 2002K022083HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER
The Binding Site, Ltd.
CFN
Aug 31, 2001K012296HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T
The Binding Site, Ltd.
CFN
Aug 31, 2001K012292HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB
The Binding Site, Ltd.
CFN
Aug 20, 2001K012295HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T
The Binding Site, Ltd.
CFN
Aug 20, 2001K012291HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA
The Binding Site, Ltd.
CFN
Apr 27, 2000K000701HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER
The Binding Site, Ltd.
CFN
Feb 1, 2000K993549BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR
Beckman Coulter, Inc.
CFN
Feb 1, 2000K993547BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB
Beckman Coulter, Inc.
CFN
Jan 14, 2000K993924WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
Wako Chemicals USA, Inc.
CFN
Dec 21, 1999K981784IGM MININEPH ANTISERUM
The Binding Site, Ltd.
CFN
Dec 20, 1999K982100IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS
The Binding Site, Ltd.
CFN
Dec 4, 1998K981912HUMAN IGA SUBCLASS BNII COMBI KIT
The Binding Site, Ltd.
CFN
Sep 28, 1998K982382COBAS INTEGRA REAGENT CASSETTES
Roche Diagnostic Systems, Inc.
CFN
Mar 22, 1994K933971N-ASSAY TIA IGA
Crestat Diagnostics, Inc.
CFN

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