DHR · Class II · 21 CFR 866.5775

FDA Product Code DHR: System, Test, Rheumatoid Factor

Leading manufacturers include Beckman Instruments, Inc., Bd Becton Dickinson Vacutainer Systems Preanalytic and Bio-Rad.

144
Total
144
Cleared
80d
Avg days
1976
Since

FDA 510(k) Cleared System, Test, Rheumatoid Factor Devices (Product Code DHR)

144 devices
1–24 of 144
Cleared May 20, 2020
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
K192727
Kamiya Biomedical Company
Immunology · 236d
Cleared Apr 17, 2019
QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
K190088
Inova Diagnostics, Inc.
Immunology · 90d
Cleared Dec 18, 2018
EliA RF IgM Immunoassay
K182747
Phadia AB
Immunology · 81d
Cleared Aug 08, 2007
N LATEX RF KIT
K071247
Dade Behring, Inc.
Immunology · 96d
Cleared Sep 10, 2003
MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K032535
Roche Diagnostics Corp.
Immunology · 23d
Cleared Jan 15, 2003
RHEUMATOID FACTOR (RF)
K024067
Abbott Laboratories
Immunology · 36d
Cleared Sep 05, 2000
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K002609
Roche Diagnostics Corp.
Immunology · 14d
Cleared Apr 05, 2000
COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
K000534
Roche Diagnostics Corp.
Immunology · 48d
Cleared Apr 07, 1999
ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
K990587
Bio-Rad
Immunology · 43d
Cleared Mar 08, 1999
RF
K990035
Abbott Laboratories
Immunology · 61d
Cleared Oct 22, 1997
QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
K973464
Instrumentation Laboratory CO
Immunology · 40d
Cleared Jun 27, 1997
ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
K971602
Beckman Instruments, Inc.
Immunology · 57d
Cleared Jun 17, 1997
TINAQUANT RHEUMATOID FACTOR ASSAY
K971379
Boehringer Mannheim Corp.
Immunology · 64d
Cleared Jun 03, 1997
SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR
K971788
Beckman Instruments, Inc.
Immunology · 20d
Cleared Nov 04, 1996
IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
K963048
Beckman Instruments, Inc.
Immunology · 90d
Cleared Jun 04, 1996
LIQUICHEK RHEUMATOID FACTOR CONTROL
K960987
Bio-Rad
Immunology · 85d
Cleared Oct 06, 1992
LIQUICHEK RHEUMATOID FACTOR CONTROL
K923578
Bio-Rad
Immunology · 78d
Cleared Mar 01, 1985
ABBOTT RF EIA DIAGNOSTIC KIT
K850373
Abbott Laboratories
Chemistry · 29d
Cleared Oct 25, 1984
RHEUMADX LATEX AGGLUTINATION RHEUMATOID
K843896
Diagnostic Products Corp.
Immunology · 22d
Cleared Feb 10, 1984
SOPHEIA MP IGM RHEUMATOID FACTOR EIA
K840049
Diagnostic Products Corp.
Immunology · 35d
Cleared Mar 11, 1981
RHEUMATOID FACTOR REAGENT TEST KIT
K810306
Beckman Instruments, Inc.
Immunology · 34d
Cleared Dec 18, 1980
RHEUMATOID FACTOR TEST SYSTEMS
K802688
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 50d
Cleared Feb 21, 1980
AUTOMATED RHEMATOID FACTOR TEST (ARFT)
K800268
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 15d
Cleared Nov 27, 1979
CORDIA RF
K792061
Cordis Corp.
Immunology · 43d

About Product Code DHR - Regulatory Context