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510(k) K003412

Device
ADVIA CENTAUR RUBELLA IGG ASSAY
Applicant
BAYER CORP.
510(k) number
K003412
Product code
LFX  
Decision
Substantially Equivalent (SESE)
Decision date
2001-04-13
Date received
2000-11-02
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
William J Pignato
Address
63 N. St. Medfield MA US 02052 02052

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
K001875DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEMDiamedix Corp.2000-08-21

Legacy Summary#

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FDA Review#

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