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510(k) K233946

Device
IMMULITE® 2000 BR-MA
Applicant
Siemens Healthcare Diagnostics Products, Ltd.
510(k) number
K233946
Product code
MOI
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-13
Date received
2023-12-14
Regulation
866.6010
Classification name
System, Test, Immunological, Antigen, Tumor
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Karlyn Kellogg
Address
Glyn Rhonwy, Llanberis Caernarfon Llanberis GB LL55 4EL LL55 4EL

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MOI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240403Access BR MonitorBeckman Coulter, Inc.2024-05-09
K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc.2020-09-04
K193489ADVIA Centaur BRSiemens Healthcare Diagnostics, Inc.2020-02-13
K192777ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc.2019-11-22
K181492Elecsys CA 15-3 IIRoche Diagnostics2018-06-22
K171605Elecsys CA 15-3 IIRoche Diagnostics2018-02-20
K100344DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605Siemens Healthcare Diagnostics2011-04-18
K072612ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647Beckman Coulter, Inc.2007-10-26
K042732ARCHITECT CA 15-3 ASSAYFujirebio Diagnostics,Inc.2004-12-22
K033036BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647Beckman Coulter, Inc.2004-02-03
K022178CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics Corp.2002-11-12
K013984IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBRDiagnostic Products Corp.2002-03-28
K012357CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEMBayer Diagnostics Corp.2002-02-28
K010796AIA-PACK BRCA, ST AIA PACK BRCATosoh Medics, Inc.2001-08-16
K010588ELECSYSCA 15-3 II ASSAYRoche Diagnostics Corp.2001-03-28