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

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
K963645	ARMKEL, LLC.	HERPES GROUP IGG ELISA TEST SYSTEM	02/04/1997
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
K983541	GULL LABORATORIES, INC.	HSV 1+2 IGG ELISA TEST	02/26/1999
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
K963282	QUEST INTL., INC.	SERAQUEST HSV IGG	01/22/1997
K033059	TRINITY BIOTECH, INC.	HERPES GROUP IGG	11/26/2003
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