CFN · Class II · 21 CFR 866.5510

FDA Product Code CFN: Method, Nephelometric, Immunoglobulins (g, A, M)

Leading manufacturers include The Binding Site Group , Ltd., The Binding Site, Ltd. and Dade Behring, Inc..

61
Total
61
Cleared
146d
Avg days
1977
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Method, Nephelometric, Immunoglobulins (g, A, M) Devices (Product Code CFN)

61 devices
1–24 of 61
Cleared Dec 13, 2023
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
K233663
Siemens Healthcare Diagnostics Products GmbH
Immunology · 28d
Cleared Aug 02, 2023
Immunoglobulin G (IgG)
K221114
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
Immunology · 474d
Cleared Sep 04, 2019
Human IgA liquid reagent kit for Use on SPAPlus
K192116
The Binding Site Group , Ltd.
Immunology · 29d
Cleared Aug 19, 2019
Optilite IgA Kit
K191985
The Binding Site Group , Ltd.
Immunology · 25d
Cleared Jul 15, 2019
Optilite IgM Kit
K191635
The Binding Site Group , Ltd.
Immunology · 26d
Cleared Jun 27, 2019
Human IgM Kit for use on SPAPlus
K191465
The Binding Site Group , Ltd.
Immunology · 24d
Cleared May 28, 2019
Optilite IgM CSF Kit
K190686
The Binding Site Group , Ltd.
Immunology · 71d
Cleared Jan 23, 2019
Optilite IgA CSF Kit
K183151
The Binding Site Group , Ltd.
Immunology · 70d
Cleared Jan 09, 2017
DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
K162208
Beckman Coulter, Inc.
Immunology · 157d
Cleared May 30, 2015
Optilite IgG4 Kit
K150526
The Binding Site Group , Ltd.
Immunology · 89d
Cleared Dec 21, 2014
The Optilite IgG3 kit
K142735
The Binding Site Group , Ltd.
Immunology · 89d
Cleared Jan 07, 2014
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
K130122
Beckman Coulter, Inc.
Immunology · 355d
Cleared May 30, 2013
HUMAN IGA CSF KIT FOR USE ON SPAPLUS
K120901
The Binding Site Group , Ltd.
Immunology · 430d
Cleared May 17, 2013
HUMAN IGG CSF KIT
K120749
The Binding Site Group , Ltd.
Immunology · 431d
Cleared May 17, 2013
HUMAN IGM CSF KIT
K120750
The Binding Site Group , Ltd.
Immunology · 431d
Cleared Mar 27, 2013
HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT
K113823
The Binding Site Group , Ltd.
Immunology · 456d
Cleared Aug 16, 2010
HUMAN IGA2 KIT FOR USE ON THE SPAPLUS
K100588
The Binding Site Group , Ltd.
Immunology · 167d
Cleared Mar 01, 2010
HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS
K082823
The Binding Site Group , Ltd.
Immunology · 522d
Cleared Dec 30, 2009
HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
K090920
The Binding Site, Ltd.
Immunology · 273d
Cleared Apr 29, 2009
DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID
K090594
Siemens Healthcare Diagnostics
Immunology · 55d
Cleared Mar 24, 2009
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC
K083445
Siemens Healthcare Diagnostics
Immunology · 123d
Cleared Feb 10, 2009
HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
K082129
The Binding Site, Ltd.
Immunology · 196d
Cleared Dec 19, 2008
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
K081827
The Binding Site, Ltd.
Immunology · 175d
Cleared Jul 28, 2008
DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST
K081161
Dade Behring, Inc.
Immunology · 95d

About Product Code CFN - Regulatory Context

510(k) Submission Activity

61 total 510(k) submissions under product code CFN since 1977, with 61 receiving FDA clearance (average review time: 146 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.