ClearanceBrief
Panels › Immunology › Product code DHR · Class 2

System, Test, Rheumatoid Factor

Regulation 866.5775

0510(k)s in 12 months (144 all time)
0recalls in 12 months (15 all time)
15recalls that name a 510(k)
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Top companies in DHR

Company510(k)sRecalls
Behring Diagnostics, Inc.50
The Binding Site Group , Ltd.23
Beckman Coulter Inc.04
Beckman Instruments, Inc.40
Hycor Biomedical, Inc.22
Inova Diagnostics, Inc.40
Kamiya Biomedical Co.40
Zeus Scientific, Inc.31
Abbott Laboratories30
Bd Becton Dickinson Vacutainer Systems Preanalytic30
Decided510(k)Device and applicantCode
May 20, 2020K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
Kamiya Biomedical Company
DHR
Apr 17, 2019K190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
Inova Diagnostics, Inc.
DHR
Dec 18, 2018K182747EliA RF IgM Immunoassay
Phadia AB, SE
DHR
May 3, 2017K162263Optilite Rheumatoid Factor Kit
The Binding Site Group , Ltd., GB
DHR
Dec 7, 2016K160070Rheumatoid Factor (RF) Kit for use on SPAPLUS
The Binding Site Group , Ltd., GB
DHR
Sep 23, 2015K143736ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELIS
Immco Diagnostics, Inc.
DHR
Sep 30, 2011K102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
Phadia US, Inc.
DHR
Oct 27, 2010K100499ORGENTEC RHEUMATOID FACTOR EIA
Orgentec Diagnostika GmbH
DHR
Oct 29, 2009K083080IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM
Sqi Diagnostics Systems, CA
DHR
Aug 8, 2007K071247N LATEX RF KIT
Dade Behring, Inc.
DHR
Jun 6, 2006K060201OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.
Olympus America, Inc.
DHR
Nov 5, 2004K041891MININEPH HUMAN RHEUMATOID FACTOR KIT
The Binding Site
DHR
Sep 20, 2004K041863VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS
Ortho-Clinical Diagnostics, Inc.
DHR
Feb 27, 2004K033802ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM
Zeus Scientific, Inc.
DHR
Sep 10, 2003K032535MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
Roche Diagnostics Corp.
DHR
Jan 15, 2003K024067RHEUMATOID FACTOR (RF)
Abbott Laboratories
DHR
Sep 9, 2002K020972WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET
Wako Chemicals USA, Inc.
DHR
Jul 9, 2002K021394DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
Diamedix Corp.
DHR
Sep 5, 2000K002609TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
Roche Diagnostics Corp.
DHR
Apr 5, 2000K000534COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
Roche Diagnostics Corp.
DHR
Mar 3, 2000K993557AUTOSTAT II RHEUMATOID FACTOR IGA ELISA
Cogent Diagnotics , Ltd., GB
DHR
Feb 3, 2000K994338AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
Cogent Diagnotics , Ltd., GB
DHR
Jan 11, 2000K993843MDI RF TEST
Micro Detect, Inc.
DHR
Dec 6, 1999K993304AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
Cogent Diagnotics , Ltd., GB
DHR
Jun 10, 1999K991467K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET
Kamiya Biomedical Co.
DHR
Jun 9, 1999K991409K-ASSAY RHEUMATOID FACTOR
Kamiya Biomedical Co.
DHR
Apr 7, 1999K990587ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
Bio-Rad
DHR
Mar 8, 1999K990035RF
Abbott Laboratories
DHR
Jan 25, 1999K984045RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS
Kamiya Biomedical Co.
DHR
Nov 18, 1998K983418THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL
Zeus Scientific, Inc.
DHR
Nov 4, 1998K983084QUANTA LITE RF IGA ELISA
Inova Diagnostics, Inc.
DHR
Nov 4, 1998K983083QUANTA LITE RF IGG ELISA
Inova Diagnostics, Inc.
DHR
Jun 15, 1998K981496COLOR-SLIDE RF
Seradyn, Inc.
DHR
Mar 6, 1998K974889DIAMEDIX IS-RF TEST SYSTEM
Diamedix Corp.
DHR
Feb 17, 1998K974370RAPET RF
Stanbio Laboratory
DHR
Nov 25, 1997K972456RHEUMACOL RHEUMATOID FACTOR TEST
Immunostics Inc.,
DHR
Oct 22, 1997K973464QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
Instrumentation Laboratory CO
DHR
Sep 9, 1997K972220RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT
Randox Laboratories, Ltd., IE
DHR
Jun 27, 1997K971602ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
Beckman Instruments, Inc.
DHR
Jun 20, 1997K971614QUANTA LITE RF IGM
Inova Diagnostics, Inc.
DHR
Jun 17, 1997K971379TINAQUANT RHEUMATOID FACTOR ASSAY
Boehringer Mannheim Corp.
DHR
Jun 3, 1997K971788SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR
Beckman Instruments, Inc.
DHR
Apr 17, 1997K970373RAICHEM RHEUMATOID FACTOR SPIA
Henage Diagnostics, Inc.
DHR
Mar 7, 1997K962729HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY
Hycor Biomedical, Inc.
DHR
Dec 16, 1996K962050THERATEST EL-RFSCR
Theratest Laboratories, Inc.
DHR
Dec 13, 1996K964418N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET
Kamiya Technology Services
DHR
Dec 13, 1996K964415N-ASSAY TIA RHEUMATOID FACTOR TEST KIT
Kamiya Technology Services
DHR
Nov 25, 1996K962015RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST
Teco Diagnostics
DHR
Nov 4, 1996K963048IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
Beckman Instruments, Inc.
DHR
Sep 24, 1996K961545QUALITROL RF CONTROLS
Consolidated Technologies, Inc.
DHR

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