FDA.report

510(k) K250588

Device
Access Rubella IgG
Applicant
Beckman Coulter, Inc.
510(k) number
K250588
Product code
LFX
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-17
Date received
2025-02-27
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
N

Related Records

Applicant Contact

Contact
Audree Demmers
Address
1000 Lake Hazeltine Dr. Chaska MN US 55318 55318

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code LFX

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K243168Alinity i Rubella IgGAbbott Laboratories2025-06-20
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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
K001875DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEMDiamedix Corp.2000-08-21