FDA 510(k) Applications for Medical Device Product Code: LJO (Antigen, Iha, Cytomegalovirus)

FDA 510(k) Applications for Medical Device Product Code "LJO"
(Antigen, Iha, Cytomegalovirus)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K001767	DIAMEDIX CORP.	DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM	08/07/2000
K974901	DIGENE CORP.	HYBRID CAPTURE SYSTEM CMV DNA ASSAY	09/29/1998
K951851	E.I. DUPONT DE NEMOURS & CO., INC.	ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY	07/24/1996
K183571	Immucor, Inc.	Capture-CMV	02/04/2019
K203612	Immucor, Inc.	Capture-CMV	03/22/2021
K974456	INSTRUMENTATION LABORATORY CO.	CMVGEN	05/01/1998
K955799	SIENNA BIOTECH, INC.	COPALIS CMV TOTAL ANTIBODY ASSAY	07/10/1996