FDA 510(k) Applications for Medical Device Product Code "LFX"
(Enzyme Linked Immunoabsorbent Assay, Rubella)

FDA 510(k) Number Applicant Device Name Decision Date
K903308 AB SANGTEC MEDICAL TRANSTAT-CMV(TM) 12/04/1990
K954318 ABBOTT LABORATORIES ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY 05/14/1996
K954045 ABBOTT LABORATORIES AXSYM RUBELLA IGG ANTIBODY ASSAY 09/24/1996
K951541 ABBOTT LABORATORIES IMX RUBELLA IGG 07/16/1996
K885297 ABBOTT LABORATORIES IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY 06/23/1989
K931059 ABBOTT LABORATORIES IMX RUBELLA IGM ANTIBODY ASSAY 12/19/1994
K885295 ABBOTT LABORATORIES IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY 06/23/1989
K791746 ABBOTT LABORATORIES ROTAZYME 11/16/1979
K882475 AMERSHAM CORP. AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200 10/06/1988
K922586 BAXTER DIAGNOSTICS, INC. BARTELS RUBELLA IGG EIA 09/17/1992
K922581 BAXTER DIAGNOSTICS, INC. BARTELS RUBELLA IGM EIA 09/17/1992
K003412 BAYER CORP. ADVIA CENTAUR RUBELLA IGG ASSAY 04/13/2001
K010668 BAYER CORP. BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY 07/05/2001
K951359 BAYER CORP. RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE 04/15/1996
K952721 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUBASCAN CARD TEST 12/20/1996
K031606 BECKMAN COULTER, INC. ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY 06/20/2003
K092587 Bio-Rad Laboratories BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM 12/03/2010
K954687 BIO-RAD LABORATORIES, INC. ACCESS RUBELLA IGG 04/09/1996
K950227 BIO-WHITTAKER, INC., A CAMBREX CO. RUBELISA (RUBESTAT) 08/15/1995
K080766 BIOMERIEUX, INC. VIDAS RUB IGG 12/23/2008
K894544 BIOTROL, USA, INC. BIOTROL RUB-E.I.A. TEST G 08/30/1989
K813493 CALBIOCHEM-BEHRING CORP. ENZYGNOST TM RUBELLA IGM 03/04/1982
K921573 CLARK LABORATORIES, INC. RUBELLA IGM 08/27/1992
K860145 CLINICAL SCIENCES, INC. RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540 07/14/1986
K854618 CORDIS CORP. CORDOT R 05/01/1986
K883182 CYBERFLUOR, INC. FIAGEN RUBELLA IGG 10/31/1988
K864315 CYTOTECH, INC. CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY 02/02/1987
K963613 DIAGNOSTIC PRODUCTS CORP. IMMULITE RUBELLA IGG 04/02/1997
K012077 DIAGNOSTIC PRODUCTS CORP. IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6 01/10/2002
K982078 DIAGNOSTIC PRODUCTS CORP. IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS) 12/11/1998
K001875 DIAMEDIX CORP. DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM 08/21/2000
K981729 DIAMEDIX CORP. IS-RUBELLA IGG TEST SYSTEM 01/28/1999
K093101 DIAMEDIX CORP. MAGO 4S 01/21/2011
K883778 DIAMEDIX CORP. RUBELLA IGM MICROASSAY 10/25/1988
K864602 DIAMEDIX CORP. RUBELLA MICROASSAY 04/14/1987
K993291 DIASORIN, INC. COPALIS RUBELLA IGM 02/10/2000
K073390 DIASORIN, INC. DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS 11/21/2008
K122397 DIASORIN, INC. LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM 09/06/2012
K892051 DIFCO LABORATORIES, INC. RUBELLA-CUBE(TM) 06/08/1989
K902571 DISEASE DETECTION INTERNATIONAL, INC. MODIFICATION OF SEROCARD RUBELLA IGG TEST 09/05/1990
K884247 DISEASE DETECTION INTERNATIONAL, INC. MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT 04/10/1989
K875368 DISEASE DETECTION INTERNATIONAL, INC. THE DDI SERODOT RUBELLA IGG TEST KIT 03/23/1988
K873088 ELECTRO-NUCLEONICS LABORATORIES, INC. VIRGO(TM) RUBELLA IGG ELISA 09/09/1987
K885082 GENERAL BIOMETRICS, INC. IMMUNODOT RUBELLA TEST 02/02/1989
K894546 GENERAL BIOMETRICS, INC. IMMUNODOT RUBELLA TEST 10/16/1989
K884898 GENERAL BIOMETRICS, INC. IMMUNODOT TORCH TEST RUBELLA 02/03/1989
K812787 GILFORD EIA RUBELLA 11/27/1981
K892202 GULL LABORATORIES, INC. DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST 09/13/1989
K915893 GULL LABORATORIES, INC. RUBELLA IGG ELISA TEST 03/04/1992
K941624 GULL LABORATORIES, INC. RUBELLA IGG ELISA TEST 08/04/1995
K901635 GULL LABORATORIES, INC. RUBELLA IGG ELISA TEST 06/28/1990
K904084 GULL LABORATORIES, INC. RUBELLA IGM ELISA TEST 12/04/1990
K853069 HYBRITECH, INC. TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT 01/01/1986
K960367 INCSTAR CORP. INCSTAR RUBELLA IGG ELISA ASSAY 10/24/1996
K960358 INCSTAR CORP. INCSTAR RUBELLA IGG FAST ELISA ASSAY 10/24/1996
K971304 INOVA DIAGNOSTICS, INC. QUANTA LITE REBELLA IGG 01/02/1998
K872071 ISMUNIT ISTITUTO IMMUNOLOGICO INTALIANO CHROMOTITRE E.I.A. RUBELLA IGG 08/24/1987
K894946 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. PLATELIA RUBELLA IGG KIT 12/21/1989
K873780 LABSYSTEMS, INC. MODIFICATION RUBELLA IGM EIA TEST KIT 10/15/1987
K890091 LABSYSTEMS, INC. MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT 02/03/1989
K881243 LABSYSTEMS, INC. RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201 04/04/1988
K853696 LABSYSTEMS, INC. RUBELLA IGG EIA TEST KIT 06/17/1986
K862431 LABSYSTEMS, INC. RUBELLA IGM EIA TEST KIT 08/08/1986
K821804 LITTON BIONETICS RUBELLA RQ BIO-ENZABEAD KIT 09/14/1982
K883924 MERCIA DIAGNOSTICS LTD. CAPTIA(R) RUBELLA-G 08/15/1989
K885300 MERCIA DIAGNOSTICS LTD. CAPTIA(R) RUBELLA-M 08/15/1989
K803133 MICROBIOLOGICAL RESEARCH CORP. RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL 01/29/1981
K803175 MICROBIOLOGICAL RESEARCH CORP. RUBELLA VIRUS SEROLOGICAL REAGENTS 01/29/1981
K861282 MUREX CORP. MUREX SUDS RUBELLA 06/13/1986
K911393 ORGANON TEKNIKA CORP. RUBENOSTIKA IGG MICROELISA SYSTEM 04/29/1991
K882999 ORGANON TEKNIKA CORP. RUBENOSTIKA(TM) IGM MICROELISA SYSTEM 01/31/1989
K884617 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY 02/02/1989
K822342 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO RUBELLA ELISA TEST SYSTEM 03/17/1983
K905079 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO RUBELLA-M ANTIBODY ELISA TEST 12/04/1990
K896479 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO* RUBELLA-G ANTIBODY ELISA TEST 12/29/1989
K841200 ORTHO DIAGNOSTIC SYSTEMS, INC. RUBELLA IGG ANTIBODY ELISA TEST SYS 05/21/1984
K063143 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS 12/26/2006
K915870 PB DIAGNOSTICS, INC. OPUS RUBELLA TEST SYSTEM 03/23/1992
K902793 PHARMACIA DIAGNOSTICS, INC. RUBELLA IGG 07/31/1990
K925355 PRINCETON BIOMEDIX BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST 07/12/1994
K961053 QUEST INTL., INC. SERAQUEST RUBELLA IGG 09/04/1996
K982281 QUEST INTL., INC. SERAQUEST RUBELLA IGM 10/16/1998
K092322 Roche Diagnostics ELECSYS RUBELLA IGM IMMUNOASSAY 03/12/2010
K072617 ROCHE DIAGNOSTICS CORP. ELECSYS RUBELLA IGG IMMUNOASSAY 12/05/2008
K914420 SCLAVO, INC. ELISA RUBELLA IGM 12/27/1991
K902925 VITEK SYSTEMS, INC. VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG) 08/09/1990
K911444 WAMPOLE LABORATORIES RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM 08/30/1991
K063186 ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM 03/21/2007
K891783 ZEUS SCIENTIFIC, INC. RUBELLA ELISA TEST SYSTEM 08/03/1989
K914028 ZEUS SCIENTIFIC, INC. RUBELLA IGM ELISA TEST SYSTEM 04/22/1992
K983805 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO 05/26/1999
K984180 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM 07/20/1999


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