FDA.reportPublic FDA data

510(k) K022178

Device
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
Applicant
Bayer Diagnostics Corp.
510(k) number
K022178
Product code
MOI
Decision
Substantially Equivalent (SESE)
Decision date
2002-11-12
Date received
2002-07-03
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
KENNETH T EDDS
Address
511 Benedict Ave. Tarrytown NY US 10591 10591

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc.2020-09-04
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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
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