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 Jul 28, 1992
WAKO AUTOKIT RF
K922151
Wako Chemicals USA, Inc.
Immunology · 82d
Cleared Mar 30, 1992
RF STAT IGM TEST KIT
K920753
Biowhittaker Molecular Applications, Inc.
Immunology · 40d
Cleared Mar 13, 1992
HEALTHTEST RHEUMATOID FACTOR ASSAY
K920220
Akers Research Corp.
Immunology · 57d
Cleared Mar 02, 1992
TURBIQUANT
K920124
Behring Diagnostics, Inc.
Immunology · 52d
Cleared May 31, 1991
RHEUMAGEN RF T-CONTROL
K904310
Biokit USA, Inc.
Immunology · 254d
Cleared Apr 05, 1991
RHEUMAJET RF
K910539
Biokit USA, Inc.
Immunology · 67d
Cleared Oct 29, 1990
CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST
K904498
Biotrax, Inc.
Immunology · 27d
Cleared Oct 15, 1990
V-TREND TARGET RF TEST
K904105
Texas Immunology, Inc.
Immunology · 39d
Cleared Aug 30, 1990
RAPITEX(R) RF NEW
K903852
Behring Diagnostics, Inc.
Immunology · 9d
Cleared Jun 21, 1990
MODIFIED QM300 RHEUMATOID FACTOR TEST
K902462
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 17d
Cleared Nov 08, 1989
QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)
K896271
Biokit USA, Inc.
Immunology · 9d
Cleared Aug 10, 1989
TECHNICON DPA-1 SYSTEM RF METHOD
K894574
Technicon Instruments Corp.
Immunology · 20d
Cleared Jun 05, 1989
REAADS-RF TEST KIT-QUANTITATIVE
K892444
Biosearch Medical Products, Inc.
Immunology · 56d
Cleared Jun 05, 1989
REAADS-RF TEST KIT-SEMIQUANTITATIVE
K892445
Biosearch Medical Products, Inc.
Immunology · 56d
Cleared Feb 03, 1989
TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
K884180
Unipath , Ltd.
Immunology · 126d
Cleared Sep 07, 1988
UBI MAGIWEL RF-IGM QUANTITATIVE
K883355
United Biotech, Inc.
Immunology · 29d
Cleared Sep 07, 1988
QM300 RHEUMATOID FACTOR ANTIGEN PACK
K883536
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 20d
Cleared Sep 07, 1988
QM300 CALIBRATOR E PACK
K883538
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 20d
Cleared Feb 10, 1988
RF CARD TEST & RF LIQUID TEST
K880164
Ampcor, Inc.
Immunology · 28d
Cleared Dec 29, 1987
RF DIPSTICK TEST KIT
K874151
Lipogen, Inc.
Immunology · 77d
Cleared Nov 27, 1987
REUMA TEST
K873782
Sclavo, Inc.
Immunology · 72d
Cleared Nov 04, 1987
AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT
K873064
Amtec Diagnostics International, Inc.
Immunology · 91d
Cleared May 06, 1987
RHEUMA-CHECK ENZYME IMMUNOASSAY TEST
K871196
Orion Diagnostica, Inc.
Immunology · 43d
Cleared Mar 31, 1987
RF MICROASSAY
K871041
Diamedix Corp.
Microbiology · 14d