FDA.reportPublic FDA data

510(k) K203612

Device
Capture-CMV
Applicant
Immucor, Inc.
510(k) number
K203612
Product code
LJO
Decision
Substantially Equivalent (SESE)
Decision date
2021-03-22
Date received
2020-12-10
Regulation
866.3175
Classification name
Antigen, Iha, Cytomegalovirus
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Steven Appel
Address
3130 Gateway Dr. Norcross GA US 30071 30071

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LJO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K183571Capture-CMVImmucor, Inc.2019-02-04
K001767DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEMDiamedix Corp.2000-08-07
K974901HYBRID CAPTURE SYSTEM CMV DNA ASSAYDigene Corp.1998-09-29
K974456CMVGENInstrumentation Laboratory CO1998-05-01
K951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYE.I. Dupont DE Nemours & Co., Inc.1996-07-24
K955799COPALIS CMV TOTAL ANTIBODY ASSAYSienna Biotech, Inc.1996-07-10
K920222HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUSAkers Research Corp.1992-07-27
K910003CYTOMEGALOVIRUS ANTIBODY SCREENImmucor, Inc.1991-03-20
K852494CMV-IHAHillcrest Biologicals1985-09-16
K841520CMV LATEX AGGLUTINATION TEST KITBd Becton Dickinson Vacutainer Systems Preanalytic1984-09-07
K822965CETUS CMV IHACetus Corp.1983-02-15