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
144 devices
49–72 of 144
Cleared Nov 04, 1996
IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
K963048
Beckman Instruments, Inc.
Immunology · 90d
Cleared Sep 24, 1996
QUALITROL RF CONTROLS
K961545
Consolidated Technologies, Inc.
Immunology · 155d
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 Apr 19, 1996
RF-LATEX SEIKEN REAGENT SYSTEM
K960703
Globe Management Support, Inc.
Immunology · 59d
Cleared Dec 26, 1995
HYTEC AUTOMIMMUNE KIT (RF)
K954892
Hycor Biomedical, Inc.
Immunology · 62d
Cleared Dec 20, 1995
TEST, RHEUMATOID FACTOR
K955086
Polymedco, Inc.
Immunology · 43d
Cleared Aug 24, 1995
OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT
K953520
Olympus America, Inc.
Immunology · 28d
Cleared Aug 15, 1995
CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM
K953261
Shared Systems, Inc.
Immunology · 34d
Cleared Jul 28, 1995
EL-RF/3 (IGM-IGG-IGA) KIT
K941398
Theratest Laboratories, Inc.
Immunology · 493d
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 Jan 28, 1994
EL-RF TEST SYSTEM: EL-RF-IGM KIT
K933712
Theratest Laboratories, Inc.
Immunology · 182d
Cleared Aug 23, 1993
EYE SPOT RF TEST
K932437
J & S Medical Assoc., Inc.
Immunology · 96d
Cleared Apr 06, 1993
IMMUNO RA UNDILUTED
K926569
Immunostics Co., Inc.
Immunology · 96d
Cleared Dec 07, 1992
RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST
K915320
Trinity Laboratories, Inc.
Immunology · 381d
Cleared Dec 01, 1992
ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST
K924036
J.S. Medical Assoc.
Immunology · 112d
Cleared Oct 06, 1992
LIQUICHEK RHEUMATOID FACTOR CONTROL
K923578
Bio-Rad
Immunology · 78d
Cleared Oct 05, 1992
TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL
K922725
Simplicity Diagnostics, Inc.
Immunology · 122d
Cleared Oct 05, 1992
PULSE RF TEST
K923771
Pulse Scientific, Inc.
Immunology · 69d
Cleared Sep 25, 1992
ENCORE RHEUMATOID FACTOR EIA
K924056
Clark Laboratories, Inc.
Immunology · 44d