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510(k) K983805

Device
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
Applicant
ZEUS SCIENTIFIC, INC.
510(k) number
K983805
Product code
LFX  
Decision
Substantially Equivalent (SESE)
Decision date
1999-05-26
Date received
1998-10-28
Regulation
866.3510
Classification name
Enzyme Linked Immunoabsorbent Assay, Rubella
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 LFX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250588Access Rubella IgGBeckman Coulter, Inc.2025-11-17
K243168Alinity i Rubella IgGAbbott Laboratories2025-06-20
K122397LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGMDiaSorin, Inc.2012-09-06
K093101MAGO 4SDiamedix Corp.2011-01-21
K092587BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEMBio-Rad Laboratories2010-12-03
K092322ELECSYS RUBELLA IGM IMMUNOASSAYRoche Diagnostics2010-03-12
K080766VIDAS RUB IGGbioMerieux, Inc.2008-12-23
K072617ELECSYS RUBELLA IGG IMMUNOASSAYRoche Diagnostics Corp.2008-12-05
K073390DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLSDiaSorin, Inc.2008-11-21
K063186ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEMZeus Scientific, Inc.2007-03-21
K063143VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORSOrtho-Clinical Diagnostics, Inc.2006-12-26
K031606ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAYBeckman Coulter, Inc.2003-06-20
K012077IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6Diagnostic Products Corp.2002-01-10
K010668BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAYBayer Corp.2001-07-05
K003412ADVIA CENTAUR RUBELLA IGG ASSAYBayer Corp.2001-04-13

Legacy Summary#

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FDA Review#

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