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
Aug 1, 1985K853054RF CARD TEST
Preco, Inc.
DHR
Jun 5, 1985K851537LASER RF CONTROL SERUM-QUALITY CONTROL SERUM
Behring Diagnostics, Inc.
DHR
Apr 25, 1985K851099IGM RHEUMATOID FACTOR TEST KIT
Breit Laboratories, Inc.
DHR
Apr 12, 1985K850296LASER RF TEST -RHEUMATOID FACTOR(S) REAGENTS
Behring Diagnostics, Inc.
DHR
Mar 1, 1985K850373ABBOTT RF EIA DIAGNOSTIC KIT
Abbott Laboratories
DHR
Oct 25, 1984K843896RHEUMADX LATEX AGGLUTINATION RHEUMATOID
Diagnostic Products Corp.
DHR
Apr 25, 1984K841454RF TEST KIT
Difco Laboratories, Inc.
DHR
Apr 20, 1984K841146NCS RA LATEX TEST
Ncs Diagnostics, Inc.
DHR
Apr 4, 1984K840863SERATEST RF LATEX DETERMINATION
Seragen Diagnostics, Inc.
DHR
Feb 13, 1984K840005NABI RF-Q.S. TEST
Intl. Diagnostic, Inc.
DHR
Feb 10, 1984K840049SOPHEIA MP IGM RHEUMATOID FACTOR EIA
Diagnostic Products Corp.
DHR
Feb 3, 1984K834391IMMUNO-RA
Immunostics Co., Inc.
DHR
Jul 18, 1983K831941LEAP RHEUMATOID FACTOR TEST KIT
Cooper Diagnostics, Inc.
DHR
Jun 30, 1983K831597SERO/TEX RED CELL RF TEST
Texas Immunology, Inc.
DHR
Jun 8, 1983K831467RA-CHECK
Diagnostic Technology, Inc.
DHR
Apr 18, 1983K830832RHEUMATOID FACTOR-RAPID CARD TEST #65114
Emd Chemicals, Inc.
DHR
Mar 24, 1983K830611RA SCREENING TEST
Tago, Inc.
DHR
Oct 18, 1982K822905LATEST RF KIT FOR RHEUMATOID FACTOR
Fisher Scientific Co., LLC
DHR
Aug 27, 1982K821941RHEUMATOID FACTOR REFERENCE PREPARA.
Armkel, LLC
DHR
May 21, 1982K821319SERO/TEX RF TEST
Texas Immunology, Inc.
DHR
Dec 17, 1981K813309RA-80 POSITIVE CONTROL
Sun-Kit
DHR
Nov 6, 1981K812972RA LATEX TEST
Oxoid U.S.A., Inc.
DHR
Nov 6, 1981K812968FIAX RHEUMATOID FACTOR TEST KIT
Intl. Diagnostic Technology
DHR
Oct 26, 1981K812882RHEUMATEX
Armkel, LLC
DHR
Jun 12, 1981K811375BI-RA SLIDE TEST
Biologics Intl., Inc.
DHR
Mar 11, 1981K810404RHEUMATOID FACTORS REFERENCE SERUM
Calbiochem-Behring Corp.
DHR
Mar 11, 1981K810306RHEUMATOID FACTOR REAGENT TEST KIT
Beckman Instruments, Inc.
DHR
Feb 9, 1981K810221SCRIPPSERA THEUMATOID FACTOR REFER. CNTL
Scripps-Miles, Inc.
DHR
Feb 9, 1981K810141SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT
Scripps-Miles, Inc.
DHR
Jan 5, 1981K802448RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.
Syn-Kit, Inc.
DHR
Dec 18, 1980K802688RHEUMATOID FACTOR TEST SYSTEMS
Bd Becton Dickinson Vacutainer Systems Preanalytic
DHR
Oct 10, 1980K801961RF-II TEST KIT
Immuno-Diagnostic Products, Inc.
DHR
Feb 21, 1980K800268AUTOMATED RHEMATOID FACTOR TEST (ARFT)
Bd Becton Dickinson Vacutainer Systems Preanalytic
DHR
Jan 24, 1980K792697NORMAL GLOBULIN REAGENT
Meridian Diagnostics, Inc.
DHR
Jan 24, 1980K792695ANTI-GLOBULIN CONTROL
Meridian Diagnostics, Inc.
DHR
Dec 31, 1979K791507AGGLUTINOTEST-RHEUMATOID ARTHRITIS
Volu Sol Medical Industries
DHR
Nov 27, 1979K792061CORDIA RF
Cordis Corp.
DHR
Mar 15, 1979K790351RHEUMATELL
Central Biological Co.
DHR
Jan 26, 1979K790012RHEUMOGEN TEST SYSTEM
Calbiochem-Behring Corp.
DHR
Nov 2, 1977K771940QUANTROLS RF
Organon, Inc.
DHR
Sep 2, 1977K771410RHEUMANOSTICON R
Organon, Inc.
DHR
Aug 30, 1977K771552LAS-R RHEUMATOID FACTOR TEST
Hyland Therapeutic Div., Travenol Laboratories
DHR
Aug 3, 1976K760043TEST, RHEUM. ARTH., CARD (MACRO-VUE)
Bd Becton Dickinson Vacutainer Systems Preanalytic
DHR
Aug 3, 1976K760036TEST, LATEX SLIDE, RHEUMATOID FACTOR
Gamma Biologicals, Inc.
DHR

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