FDA 510(k) Applications for Medical Device Product Code "LJN"
(Antibody Igm, If, Epstein-Barr Virus)

FDA 510(k) Number Applicant Device Name Decision Date
K911362 AMICO LABORATORIES, INC. AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST 10/07/1991
K922331 BAXTER DIAGNOSTICS, INC. BARTELS EPSTEIN-BARR VIRUS IGM EIA 09/02/1992
K123021 Bio-Rad Laboratories BIOPLEX 2200 EBV IGM KIT 11/02/2012
K893240 BION ENT., LTD. BION EBV-M (VCA) TEST SYSTEM 07/14/1989
K890639 DIAGNOSTIC TECHNOLOGY, INC. RESUBMITTED EBV/IGM-CHECK TEST KIT 06/20/1989
K991459 DIASORIN, INC. COPALIS EBV-M ANTIBODY ASSAY 05/14/1999
K875204 E.I. DUPONT DE NEMOURS & CO., INC. DU PONT VCA-IGM ANTIBODY ELISA KIT 07/08/1988
K073381 FOCUS DIAGNOSTICS, INC. PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M 08/04/2008
K973939 GenBio IMMUNOWELL VCA IGM TEST 08/10/1998
K901840 GRANBIO, INC. (EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM 09/12/1990
K864604 GRANBIO, INC. EBV VCA IGM ANTIBODY ASSAY KIT 02/02/1987
K910042 GULL LABORATORIES, INC. EBV IGM ELISA TEST 02/21/1991
K896594 HILLCREST BIOLOGICALS EBV VCA ANTIBODY (IGM) 01/16/1990
K880884 IMMUNO CONCEPTS, INC. EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME) 08/30/1988
K880886 IMMUNO CONCEPTS, INC. EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT) 08/30/1988
K931520 MRL DIAGNOSTICS EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY 04/26/1994
K872541 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO. 05/13/1988
K930020 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA 07/16/1993
K915348 PHARMACIA DIAGNOSTICS, INC. EBV-VCA IGM ELISA 02/14/1992
K033780 QUEST INTL., INC. MODIFICATION TO SERAQUEST VCA IGM 01/15/2004
K990977 QUEST INTL., INC. SERAQUEST EB VAC IGM 10/06/1999
K042092 ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM 04/12/2005
K833014 ZEUS SCIENTIFIC, INC. EBV-VCA-IGM IFA TEST SYSTEM 12/27/1983


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