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
73–96 of 144
Cleared Dec 18, 1980
RHEUMATOID FACTOR TEST SYSTEMS
K802688
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 50d
Cleared Feb 21, 1980
AUTOMATED RHEMATOID FACTOR TEST (ARFT)
K800268
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 15d
Cleared Jan 24, 1980
ANTI-GLOBULIN CONTROL
K792695
Meridian Diagnostics, Inc.
Immunology · 28d
Cleared Jan 24, 1980
NORMAL GLOBULIN REAGENT
K792697
Meridian Diagnostics, Inc.
Immunology · 28d
Cleared Dec 31, 1979
AGGLUTINOTEST-RHEUMATOID ARTHRITIS
K791507
Volu Sol Medical Industries
Immunology · 152d
Cleared Nov 27, 1979
CORDIA RF
K792061
Cordis Corp.
Immunology · 43d
Cleared Jan 26, 1979
RHEUMOGEN TEST SYSTEM
K790012
Calbiochem-Behring Corp.
Immunology · 24d
Cleared Nov 02, 1977
QUANTROLS RF
K771940
Organon, Inc.
Immunology · 16d
Cleared Sep 02, 1977
RHEUMANOSTICON R
K771410
Organon, Inc.
Immunology · 32d
Cleared Aug 30, 1977
LAS-R RHEUMATOID FACTOR TEST
K771552
Hyland Therapeutic Div., Travenol Laboratories
Microbiology · 18d
Cleared Aug 03, 1976
TEST, RHEUM. ARTH., CARD (MACRO-VUE)
K760043
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 49d