510(k) K841520

Device: CMV LATEX AGGLUTINATION TEST KIT
Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number: K841520
Product code: LJO
Decision: Substantially Equivalent (SESE)
Decision date: 1984-09-07
Date received: 1984-04-12
Regulation: 866.3175
Classification name: Antigen, Iha, Cytomegalovirus
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 2
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

1034569

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LJO #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K203612	Capture-CMV	Immucor, Inc.	2021-03-22
K183571	Capture-CMV	Immucor, Inc.	2019-02-04
K001767	DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM	Diamedix Corp.	2000-08-07
K974901	HYBRID CAPTURE SYSTEM CMV DNA ASSAY	Digene Corp.	1998-09-29
K974456	CMVGEN	Instrumentation Laboratory CO	1998-05-01
K951851	ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY	E.I. Dupont DE Nemours & Co., Inc.	1996-07-24
K955799	COPALIS CMV TOTAL ANTIBODY ASSAY	Sienna Biotech, Inc.	1996-07-10
K920222	HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS	Akers Research Corp.	1992-07-27
K910003	CYTOMEGALOVIRUS ANTIBODY SCREEN	Immucor, Inc.	1991-03-20
K852494	CMV-IHA	Hillcrest Biologicals	1985-09-16
K822965	CETUS CMV IHA	Cetus Corp.	1983-02-15

Legacy Summary#

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