CFN · Class II · 21 CFR 866.5510

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

Leading manufacturers include Dade Behring, Inc., The Binding Site Group , Ltd. and Beckman Coulter, 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 Jan 07, 2014
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
K130122
Beckman Coulter, Inc.
Immunology · 355d
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
Cleared Feb 26, 2008
DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR
K073561
Dade Behring, Inc.
Immunology · 69d
Cleared Aug 24, 2006
DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H
K061845
Dade Behring, Inc.
Immunology · 56d
Cleared Jul 06, 2006
DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY
K061338
Dade Behring, Inc.
Immunology · 52d
Cleared Feb 15, 2005
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
K042735
Dade Behring, Inc.
Immunology · 137d
Cleared Aug 07, 2003
N LATEX IGM
K032014
Dade Behring, Inc.
Immunology · 38d
Cleared Feb 01, 2000
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB
K993547
Beckman Coulter, Inc.
Immunology · 105d
Cleared Feb 01, 2000
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR
K993549
Beckman Coulter, Inc.
Immunology · 105d
Cleared Sep 28, 1998
COBAS INTEGRA REAGENT CASSETTES
K982382
Roche Diagnostic Systems, Inc.
Immunology · 82d

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.