DHR · Class II · 21 CFR 866.5775

FDA Product Code DHR: System, Test, Rheumatoid Factor

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

144
Total
144
Cleared
80d
Avg days
1976
Since
144 devices
25–48 of 144
Cleared Mar 06, 1998
DIAMEDIX IS-RF TEST SYSTEM
K974889
Diamedix Corp.
Immunology · 66d
Cleared Feb 17, 1998
RAPET RF
K974370
Stanbio Laboratory
Immunology · 89d
Cleared Oct 22, 1997
QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
K973464
Instrumentation Laboratory CO
Immunology · 40d
Cleared Sep 09, 1997
RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT
K972220
Randox Laboratories, Ltd.
Immunology · 89d
Cleared Jun 27, 1997
ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
K971602
Beckman Instruments, Inc.
Immunology · 57d
Cleared Jun 20, 1997
QUANTA LITE RF IGM
K971614
Inova Diagnostics, Inc.
Immunology · 49d
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 Mar 07, 1997
HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY
K962729
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Nov 25, 1996
RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST
K962015
Teco Diagnostics
Immunology · 187d
Cleared Nov 04, 1996
IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
K963048
Beckman Instruments, Inc.
Immunology · 90d
Cleared Sep 12, 1996
HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)
K962836
Hemagen Diagnostics, Inc.
Immunology · 52d
Cleared Jun 26, 1996
RHEUMATOID FACTOR LATEX SLIDE TEST KIT
K961169
Randox Laboratories, Ltd.
Immunology · 93d
Cleared Jun 04, 1996
LIQUICHEK RHEUMATOID FACTOR CONTROL
K960987
Bio-Rad
Immunology · 85d
Cleared May 08, 1996
RF IGM ELISA TEST SYSTEM
K961277
Zeus Scientific, Inc.
Immunology · 35d
Cleared Dec 26, 1995
HYTEC AUTOMIMMUNE KIT (RF)
K954892
Hycor Biomedical, Inc.
Immunology · 62d
Cleared Aug 24, 1995
OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT
K953520
Olympus America, Inc.
Immunology · 28d
Cleared Jan 20, 1995
IGM RF EIA
K942908
Sigma Diagnostics, Inc.
Immunology · 213d
Cleared Oct 20, 1994
N LATEX RF
K942328
Behring Diagnostics, Inc.
Immunology · 168d
Cleared Sep 26, 1994
IGM RHEUMATOID FACTOR
K942272
Immco Diagnostics, Inc.
Immunology · 139d
Cleared Dec 07, 1992
RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST
K915320
Trinity Laboratories, Inc.
Immunology · 381d
Cleared Oct 06, 1992
LIQUICHEK RHEUMATOID FACTOR CONTROL
K923578
Bio-Rad
Immunology · 78d
Cleared Jul 28, 1992
WAKO AUTOKIT RF
K922151
Wako Chemicals USA, Inc.
Immunology · 82d
Cleared Mar 02, 1992
TURBIQUANT
K920124
Behring Diagnostics, Inc.
Immunology · 52d