FDA 510(k) Applications for Medical Device Product Code "LGC"
(Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific)

FDA 510(k) Number Applicant Device Name Decision Date
K843622 ABBOTT LABORATORIES ABBOTT HSV EIA 05/20/1985
K963645 ARMKEL, LLC. HERPES GROUP IGG ELISA TEST SYSTEM 02/04/1997
K802526 BARTELS & STOUT, INC. TEST KIT FOR DETECTION OF HERPES SIMPLEX 02/09/1981
K922584 BAXTER DIAGNOSTICS, INC. BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA 09/18/1992
K922334 BAXTER DIAGNOSTICS, INC. BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA 12/15/1992
K922583 BAXTER DIAGNOSTICS, INC. BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA 09/28/1992
K922333 BAXTER DIAGNOSTICS, INC. BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA 12/15/1992
K871877 BOOTS-CELLTECH DIAGNOSTICS, INC. IDEIA HERPES SIMPLEX VIRUS TEST 11/17/1989
K983886 DIAGNOLOGY LTD. POCKIT HSV 2 RAPID TEST 08/19/1999
K950670 DIAGNOSTIC PRODUCTS CORP. IMMULITE HERPES I AND II IGG 06/21/1996
K010878 DIAGNOSTIC PRODUCTS CORP. MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 04/18/2001
K981306 DIAMEDIX CORP. DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM 09/29/1998
K002262 DIAMEDIX CORP. DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM 11/28/2000
K884246 DISEASE DETECTION INTERNATIONAL, INC. MODIFIED DDI SEROCARD HERPES IGG TEST KIT 04/10/1989
K903070 DISEASE DETECTION INTERNATIONAL, INC. SEROCARD HSV IGG ANTIBODY TEST KIT 08/09/1990
K900713 E.I. DUPONT DE NEMOURS & CO., INC. HERPTRAN CONCENTRATE 05/11/1990
K903926 EASTMAN KODAK COMPANY KODAK SURECELL HERPES (HSV) CONTROL FLUID SET 09/17/1990
K884680 EASTMAN KODAK COMPANY KODAK SURECELL HERPES (HSV) TEST KIT 02/16/1989
K983541 GULL LABORATORIES, INC. HSV 1+2 IGG ELISA TEST 02/26/1999
K910954 GULL LABORATORIES, INC. HSV-1 IGG ELISA TEST 05/28/1991
K910955 GULL LABORATORIES, INC. HSV-1 IGM ELISA TEST 05/28/1991
K922758 GULL LABORATORIES, INC. HSV-1 IGM ELISA TEST -- MODIFICATION 10/05/1992
K910952 GULL LABORATORIES, INC. HSV-2 IGG ELISA TEST 05/28/1991
K910953 GULL LABORATORIES, INC. HSV-2 IGM ELISA TEST 05/28/1991
K922759 GULL LABORATORIES, INC. HSV-2 IGM ELISA TEST--MODIFICATION 10/05/1992
K822883 M.A. BIOPRODUCTS HERPELISA KIT 07/26/1983
K953839 MERIDIAN DIAGNOSTICS, INC. PREMIER HSV PLUS 05/23/1996
K984346 MERIDIAN DIAGNOSTICS, INC. PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST 06/25/1999
K000238 MRL DIAGNOSTICS HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G 04/14/2000
K834449 ORTHO DIAGNOSTIC SYSTEMS, INC. HSV ANTIGEN ELISA KIT 05/02/1984
K915551 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO HSV ANTIGEN ELISA TEST 04/22/1992
K925208 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION 12/28/1992
K963282 QUEST INTL., INC. SERAQUEST HSV IGG 01/22/1997
K843077 SCIENTIFIC RESEARCH ELISA FOR HERPES SIMPLEX VIRUS 06/21/1985
K033059 TRINITY BIOTECH, INC. HERPES GROUP IGG 11/26/2003
K910499 VITEK SYSTEMS, INC. IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS 05/01/1991
K983656 ZEUS SCIENTIFIC, INC. HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM 03/18/1999
K992166 ZEUS SCIENTIFIC, INC. THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR 09/03/1999


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