Product code CFN— Immunology
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR
- Classification name
- Method, Nephelometric, Immunoglobulins (G, A, M)
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Total cleared
- 61
- First cleared
- Most recent
Market context for product code CFN
FDA has cleared devices under product code CFN between 1977 and 2023, filed by 18 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2023
- 2019
- 2017
- 2015
- 2014
- 2013
- 2012
- 2010
- 2009
- 2008
- 2006
- 2005
- 2004
- 2003
- 2002
Top applicants under product code CFN
Recent clearances under product code CFN
- K233663 — N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
- K221114 — Immunoglobulin G (IgG)
- K192116 — Human IgA liquid reagent kit for Use on SPAPlus
- K191985 — Optilite IgA Kit
- K191635 — Optilite IgM Kit
- K191465 — Human IgM Kit for use on SPAPlus
- K190686 — Optilite IgM CSF Kit
- K183151 — Optilite IgA CSF Kit
- K162208 — DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
- K150526 — Optilite IgG4 Kit
- K142735 — The Optilite IgG3 kit
- K130122 — BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
- K120901 — HUMAN IGA CSF KIT FOR USE ON SPAPLUS
- K120749 — HUMAN IGG CSF KIT
- K120750 — HUMAN IGM CSF KIT
- K113823 — HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT
- K103824 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS
- K100588 — HUMAN IGA2 KIT FOR USE ON THE SPAPLUS
- K082823 — HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS
- K090920 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
- K090594 — DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID
- K083445 — N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC
- K082129 — HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
- K081827 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
- K081161 — DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST
- K073561 — DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR
- K073487 — OLYMPUS IGM REAGENT
- K073489 — OLYMPUS IGA REAGENT
- K073490 — OLYMPUS IGG REAGENT
- K072889 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
- K061845 — DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H
- K061338 — DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY
- K042735 — N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
- K042152 — BINDING SITE IGG SUBLCASS OLYMPUS KITS
- K042475 — VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20
- K032014 — N LATEX IGM
- K022083 — HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER
- K012292 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB
- K012296 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T
- K012291 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA
- K012295 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T
- K000701 — HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER
- K993547 — BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB
- K993549 — BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR
- K993924 — WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
- K981784 — IGM MININEPH ANTISERUM
- K982100 — IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS
- K981912 — HUMAN IGA SUBCLASS BNII COMBI KIT
- K982382 — COBAS INTEGRA REAGENT CASSETTES
- K933970 — N-ASSAY TIA IGM
- K933971 — N-ASSAY TIA IGA
- K933973 — N-ASSAY TIA MULTI V-NL
- K923070 — WAKO IGG-HA
- K880356 — N PROTEIN STANDARD PLASMA (HUMAN)
- K871343 — QM2/QM300 BUFFER AND DILUENT PACK
- K864342 — MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX
- K860894 — BEHRING NEPHELOMETER SYSTEM
- K781654 — NEPHELRATE ANTIPERUMS LGM
- K781655 — NEPHELRATE ANTISERUMS 1GA
- K781656 — NEPHELRATE ANTISERUMS, IGG
- K771226 — LAS-R TEST PROGRAM
Data sourced from openFDA. This site is unofficial and independent of the FDA.