DHR · Class II · 21 CFR 866.5775

FDA Product Code DHR: System, Test, Rheumatoid Factor

Leading manufacturers include Behring Diagnostics, Inc., Beckman Instruments, Inc. and Inova Diagnostics, Inc..

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 May 03, 2017
Optilite Rheumatoid Factor Kit
K162263
The Binding Site Group , Ltd.
Immunology · 265d
Cleared Dec 07, 2016
Rheumatoid Factor (RF) Kit for use on SPAPLUS
K160070
The Binding Site Group , Ltd.
Immunology · 329d
Cleared Sep 23, 2015
ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA
K143736
Immco Diagnostics, Inc.
Immunology · 267d
Cleared Sep 30, 2011
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
K102673
Phadia US, Inc.
Immunology · 379d
Cleared Aug 08, 2007
N LATEX RF KIT
K071247
Dade Behring, Inc.
Immunology · 96d
Cleared Jun 06, 2006
OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.
K060201
Olympus America, Inc.
Immunology · 131d
Cleared Nov 05, 2004
MININEPH HUMAN RHEUMATOID FACTOR KIT
K041891
The Binding Site
Immunology · 116d
Cleared Sep 20, 2004
VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS
K041863
Ortho-Clinical Diagnostics, Inc.
Immunology · 73d
Cleared Feb 27, 2004
ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM
K033802
Zeus Scientific, Inc.
Immunology · 81d
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 09, 2002
WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET
K020972
Wako Chemicals USA, Inc.
Immunology · 167d
Cleared Jul 09, 2002
DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
K021394
Diamedix Corp.
Immunology · 68d
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 Mar 03, 2000
AUTOSTAT II RHEUMATOID FACTOR IGA ELISA
K993557
Cogent Diagnotics , Ltd.
Immunology · 135d
Cleared Feb 03, 2000
AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
K994338
Cogent Diagnotics , Ltd.
Immunology · 42d
Cleared Jan 11, 2000
MDI RF TEST
K993843
Micro Detect, Inc.
Immunology · 60d
Cleared Dec 06, 1999
AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
K993304
Cogent Diagnotics , Ltd.
Immunology · 63d
Cleared Jun 10, 1999
K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET
K991467
Kamiya Biomedical Co.
Immunology · 44d
Cleared Jun 09, 1999
K-ASSAY RHEUMATOID FACTOR
K991409
Kamiya Biomedical Co.
Immunology · 48d

About Product Code DHR - Regulatory Context