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510(k) K983803

Device
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
Applicant
ZEUS SCIENTIFIC, INC.
510(k) number
K983803
Product code
LFZ  
Decision
Substantially Equivalent (SESE)
Decision date
1998-12-14
Date received
1998-10-28
Regulation
866.3175
Classification name
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MARK J KOPNITSKY
Address
P.O.Box 38 Raritan NJ US 08869 08869

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LFZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220949Architect CMV IgGAbbott Laboratories2022-10-27
K220911Elecsys CMV IgGRoche Diagnostics2022-10-12
K181213ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSiemens Healthcare Diagnostics, Inc.2018-07-30
K163569Elecsys CMV IgMRoche Diagnostics2017-03-17
K162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc.2017-01-06
K142133ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGMRoche Diagnostics2014-10-24
K131605ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAYRoche Diagnostics2014-02-28
K040290DIASORIN LIAISON CMV IGM/IGGDiasorin S.P.A2005-06-01
K993952IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6Diagnostic Products Corp.1999-12-16
K982485SERAQUEST CMV IGMQuest Intl., Inc.1999-01-13
K984139THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THEZeus Scientific, Inc.1999-01-11
K982027MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAYDiaSorin, Inc.1998-11-25
K981163DIAMEDIX IS-CMV IGG TEST SYSTEMDiamedix Corp.1998-09-21
K971335QUANTA LITE CMV IGG ELISAInova Diagnostics, Inc.1997-12-01
K954301ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)Abbott Laboratories1997-03-24

Legacy Summary#

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FDA Review#

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