FDA 510(k) Applications for Medical Device Product Code "DHR"
(System, Test, Rheumatoid Factor)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K990035 | ABBOTT LABORATORIES | RF | 03/08/1999 |
| K024067 | ABBOTT LABORATORIES | RHEUMATOID FACTOR (RF) | 01/15/2003 |
| K971602 | BECKMAN INSTRUMENTS, INC. | ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT | 06/27/1997 |
| K963048 | BECKMAN INSTRUMENTS, INC. | IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT | 11/04/1996 |
| K971788 | BECKMAN INSTRUMENTS, INC. | SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR | 06/03/1997 |
| K990587 | BIO-RAD | ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01 | 04/07/1999 |
| K960987 | BIO-RAD | LIQUICHEK RHEUMATOID FACTOR CONTROL | 06/04/1996 |
| K971379 | BOEHRINGER MANNHEIM CORP. | TINAQUANT RHEUMATOID FACTOR ASSAY | 06/17/1997 |
| K993557 | COGENT DIAGNOTICS LTD. | AUTOSTAT II RHEUMATOID FACTOR IGA ELISA | 03/03/2000 |
| K993304 | COGENT DIAGNOTICS LTD. | AUTOSTAT II RHEUMATOID FACTOR IGG ELISA | 12/06/1999 |
| K994338 | COGENT DIAGNOTICS LTD. | AUTOSTAT II RHEUMATOID FACTOR IGM ELISA | 02/03/2000 |
| K961545 | CONSOLIDATED TECHNOLOGIES, INC. | QUALITROL RF CONTROLS | 09/24/1996 |
| K071247 | DADE BEHRING, INC. | N LATEX RF KIT | 08/08/2007 |
| K974889 | DIAMEDIX CORP. | DIAMEDIX IS-RF TEST SYSTEM | 03/06/1998 |
| K021394 | DIAMEDIX CORP. | DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM | 07/09/2002 |
| K960703 | GLOBE MANAGEMENT SUPPORT, INC. | RF-LATEX SEIKEN REAGENT SYSTEM | 04/19/1996 |
| K962836 | HEMAGEN DIAGNOSTICS, INC. | HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) | 09/12/1996 |
| K970373 | HENAGE DIAGNOSTICS, INC. | RAICHEM RHEUMATOID FACTOR SPIA | 04/17/1997 |
| K962729 | HYCOR BIOMEDICAL, INC. | HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY | 03/07/1997 |
| K143736 | IMMCO DIAGNOSTICS, INC. | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA | 09/23/2015 |
| K972456 | IMMUNOSTICS, INC. | RHEUMACOL RHEUMATOID FACTOR TEST | 11/25/1997 |
| K190088 | Inova Diagnostics, Inc. | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents | 04/17/2019 |
| K983084 | INOVA DIAGNOSTICS, INC. | QUANTA LITE RF IGA ELISA | 11/04/1998 |
| K983083 | INOVA DIAGNOSTICS, INC. | QUANTA LITE RF IGG ELISA | 11/04/1998 |
| K971614 | INOVA DIAGNOSTICS, INC. | QUANTA LITE RF IGM | 06/20/1997 |
| K973464 | INSTRUMENTATION LABORATORY CO. | QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL) | 10/22/1997 |
| K991409 | KAMIYA BIOMEDICAL CO. | K-ASSAY RHEUMATOID FACTOR | 06/09/1999 |
| K991467 | KAMIYA BIOMEDICAL CO. | K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET | 06/10/1999 |
| K984045 | KAMIYA BIOMEDICAL CO. | RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS | 01/25/1999 |
| K192727 | Kamiya Biomedical Company | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) | 05/20/2020 |
| K964418 | KAMIYA TECHNOLOGY SERVICES | N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET | 12/13/1996 |
| K964415 | KAMIYA TECHNOLOGY SERVICES | N-ASSAY TIA RHEUMATOID FACTOR TEST KIT | 12/13/1996 |
| K993843 | MICRO DETECT, INC. | MDI RF TEST | 01/11/2000 |
| K060201 | OLYMPUS AMERICA, INC. | OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. | 06/06/2006 |
| K100499 | ORGENTEC DIAGNOSTIKA GMBH | ORGENTEC RHEUMATOID FACTOR EIA | 10/27/2010 |
| K041863 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS | 09/20/2004 |
| K182747 | Phadia AB | EliA RF IgM Immunoassay | 12/18/2018 |
| K102673 | PHADIA US INC. | RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM | 09/30/2011 |
| K961169 | RANDOX LABORATORIES, LTD. | RHEUMATOID FACTOR LATEX SLIDE TEST KIT | 06/26/1996 |
| K972220 | RANDOX LABORATORIES, LTD. | RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT | 09/09/1997 |
| K000534 | ROCHE DIAGNOSTICS CORP. | COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II | 04/05/2000 |
| K032535 | ROCHE DIAGNOSTICS CORP. | MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM | 09/10/2003 |
| K002609 | ROCHE DIAGNOSTICS CORP. | TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM | 09/05/2000 |
| K981496 | SERADYN, INC. | COLOR-SLIDE RF | 06/15/1998 |
| K083080 | SQI DIAGNOSTICS SYSTEMS | IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM | 10/29/2009 |
| K974370 | STANBIO LABORATORY | RAPET RF | 02/17/1998 |
| K962015 | TECO DIAGNOSTICS | RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST | 11/25/1996 |
| K041891 | THE BINDING SITE | MININEPH HUMAN RHEUMATOID FACTOR KIT | 11/05/2004 |
| K162263 | THE BINDING SITE GROUP LTD. | Optilite Rheumatoid Factor Kit | 05/03/2017 |
| K160070 | THE BINDING SITE GROUP, LTD. | Rheumatoid Factor (RF) Kit for use on SPAPLUS | 12/07/2016 |
| K962050 | THERATEST LABORATORIES, INC. | THERATEST EL-RFSCR | 12/16/1996 |
| K020972 | WAKO CHEMICALS, USA, INC. | WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET | 09/09/2002 |
| K033802 | ZEUS SCIENTIFIC, INC. | ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM | 02/27/2004 |
| K961277 | ZEUS SCIENTIFIC, INC. | RF IGM ELISA TEST SYSTEM | 05/08/1996 |
| K983418 | ZEUS SCIENTIFIC, INC. | THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL | 11/18/1998 |
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