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
Sep 12, 1996K962836HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)
Hemagen Diagnostics, Inc.
DHR
Jun 26, 1996K961169RHEUMATOID FACTOR LATEX SLIDE TEST KIT
Randox Laboratories, Ltd., IE
DHR
Jun 4, 1996K960987LIQUICHEK RHEUMATOID FACTOR CONTROL
Bio-Rad
DHR
May 8, 1996K961277RF IGM ELISA TEST SYSTEM
Zeus Scientific, Inc.
DHR
Apr 19, 1996K960703RF-LATEX SEIKEN REAGENT SYSTEM
Globe Management Support, Inc., JP
DHR
Dec 26, 1995K954892HYTEC AUTOMIMMUNE KIT (RF)
Hycor Biomedical, Inc.
DHR
Dec 20, 1995K955086TEST, RHEUMATOID FACTOR
Polymedco, Inc.
DHR
Aug 24, 1995K953520OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT
Olympus America, Inc.
DHR
Aug 15, 1995K953261CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM
Shared Systems, Inc.
DHR
Jul 28, 1995K941398EL-RF/3 (IGM-IGG-IGA) KIT
Theratest Laboratories, Inc.
DHR
Jan 20, 1995K942908IGM RF EIA
Sigma Diagnostics, Inc.
DHR
Oct 20, 1994K942328N LATEX RF
Behring Diagnostics, Inc.
DHR
Sep 26, 1994K942272IGM RHEUMATOID FACTOR
Immco Diagnostics, Inc.
DHR
Jan 28, 1994K933712EL-RF TEST SYSTEM: EL-RF-IGM KIT
Theratest Laboratories, Inc.
DHR
Aug 23, 1993K932437EYE SPOT RF TEST
J & S Medical Assoc., Inc.
DHR
Apr 6, 1993K926569IMMUNO RA UNDILUTED
Immunostics Co., Inc.
DHR
Dec 7, 1992K915320RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST
Trinity Laboratories, Inc.
DHR
Dec 1, 1992K924036ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST
J.S. Medical Assoc.
DHR
Oct 6, 1992K923578LIQUICHEK RHEUMATOID FACTOR CONTROL
Bio-Rad
DHR
Oct 5, 1992K923771PULSE RF TEST
Pulse Scientific, Inc., CA
DHR
Oct 5, 1992K922725TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL
Simplicity Diagnostics, Inc.
DHR
Sep 25, 1992K924056ENCORE RHEUMATOID FACTOR EIA
Clark Laboratories, Inc.
DHR
Jul 28, 1992K922151WAKO AUTOKIT RF
Wako Chemicals USA, Inc.
DHR
Mar 30, 1992K920753RF STAT IGM TEST KIT
Biowhittaker Molecular Applications, Inc.
DHR
Mar 13, 1992K920220HEALTHTEST RHEUMATOID FACTOR ASSAY
Akers Research Corp.
DHR
Mar 2, 1992K920124TURBIQUANT
Behring Diagnostics, Inc.
DHR
May 31, 1991K904310RHEUMAGEN RF T-CONTROL
Biokit USA, Inc., ES
DHR
Apr 5, 1991K910539RHEUMAJET RF
Biokit USA, Inc., ES
DHR
Oct 29, 1990K904498CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST
Biotrax, Inc.
DHR
Oct 15, 1990K904105V-TREND TARGET RF TEST
Texas Immunology, Inc.
DHR
Aug 30, 1990K903852RAPITEX(R) RF NEW
Behring Diagnostics, Inc.
DHR
Jun 21, 1990K902462MODIFIED QM300 RHEUMATOID FACTOR TEST
Kallestad Diag, A Div. of Erbamont, Inc.
DHR
Nov 8, 1989K896271QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)
Biokit USA, Inc., ES
DHR
Aug 10, 1989K894574TECHNICON DPA-1 SYSTEM RF METHOD
Technicon Instruments Corp.
DHR
Jun 5, 1989K892445REAADS-RF TEST KIT-SEMIQUANTITATIVE
Biosearch Medical Products, Inc.
DHR
Jun 5, 1989K892444REAADS-RF TEST KIT-QUANTITATIVE
Biosearch Medical Products, Inc.
DHR
Feb 3, 1989K884180TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
Unipath , Ltd., GB
DHR
Sep 7, 1988K883538QM300 CALIBRATOR E PACK
Kallestad Diag, A Div. of Erbamont, Inc.
DHR
Sep 7, 1988K883536QM300 RHEUMATOID FACTOR ANTIGEN PACK
Kallestad Diag, A Div. of Erbamont, Inc.
DHR
Sep 7, 1988K883355UBI MAGIWEL RF-IGM QUANTITATIVE
United Biotech, Inc.
DHR
Feb 10, 1988K880164RF CARD TEST & RF LIQUID TEST
Ampcor, Inc.
DHR
Dec 29, 1987K874151RF DIPSTICK TEST KIT
Lipogen, Inc.
DHR
Nov 27, 1987K873782REUMA TEST
Sclavo, Inc.
DHR
Nov 4, 1987K873064AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT
Amtec Diagnostics International, Inc.
DHR
May 6, 1987K871196RHEUMA-CHECK ENZYME IMMUNOASSAY TEST
Orion Diagnostica, Inc.
DHR
Mar 31, 1987K871041RF MICROASSAY
Diamedix Corp.
DHR
Oct 8, 1986K863238READS RF TEST KIT FOR IGM RHEUMATOID FACTOR
Biostar Medical Products, Inc.
DHR
Apr 22, 1986K855221SERATEST RF (HEMAGGLUTINATION) KIT
Hemagen Diagnostics, Inc.
DHR
Feb 6, 1986K854222DIESSE RF TEST KIT
Marvic Interpharma, Inc.
DHR
Jan 17, 1986K854820RA 80 EIKEN
Syn-Kit, Inc.
DHR

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