FDA 510(k) Applications for Medical Device Product Code "LLM"
(Test, Antigen, Nuclear, Epstein-Barr Virus)

FDA 510(k) Number Applicant Device Name Decision Date
K894626 BION ENT., LTD. EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN 10/16/1989
K980598 CLARK LABORATORIES, INC. EBNA-1 IGM ELISA TEST SYSTEM 05/01/1998
K883600 CLINICAL SCIENCES, INC. EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 05/11/1989
K883601 CLINICAL SCIENCES, INC. EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 05/11/1989
K891542 DIAGNOSTIC TECHNOLOGY, INC. EBNA-CHECK(TM) TEST KIT 06/20/1989
K040120 DIASORIN, INC. DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS 04/29/2005
K875203 E.I. DUPONT DE NEMOURS & CO., INC. DU PONT EBNA-IGG ANTIBODY ELISA KIT 08/30/1988
K925690 FULLER LABORATORIES, INC. MERIDIAN EBNA TEST KIT 10/12/1993
K973941 GenBio IMMUNOWELL EBNA IGG TEST 08/10/1998
K871298 GRANBIO, INC. EBNA ACIF ASSAY KIT 06/25/1987
K951822 GRANBIO, INC. EBNA ENZYME IMMUNOASSAY KIT 02/15/1996
K935730 GULL LABORATORIES, INC. EBNA IGG ELISA TEST 09/19/1995
K880043 GULL LABORATORIES, INC. EBV-NA TEST 03/24/1988
K875170 HILLCREST BIOLOGICALS EBNA ANTIBODY 05/23/1988
K895707 IMMUNO CONCEPTS, INC. EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY) 12/08/1989
K895708 IMMUNO CONCEPTS, INC. EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) 12/11/1989
K951549 IMMUNO PROBE, INC. EBNA IGG EIA TEST SYSTEM 04/29/1996
K946158 INCSTAR CORP. INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT 06/09/1995
K840417 LITTON BIONETICS EBNA ACIF KIT 12/27/1984
K946353 MRL DIAGNOSTICS EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY 07/21/1995
K911569 ORTHO DIAGNOSTIC SYSTEMS, INC. EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST 06/10/1991
K930002 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA 07/16/1993
K911473 WHITTAKER BIOPRODUCTS, INC. EBNA STAT TEST KIT 09/25/1991
K932742 ZEUS SCIENTIFIC, INC. EBNA IGG ELISA TEST SYSTEM 05/05/1995
K882440 ZEUS SCIENTIFIC, INC. EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST 12/15/1988
K984133 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH 01/11/1999


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