MOI · Class II · 21 CFR 866.6010

FDA Product Code MOI: System, Test, Immunological, Antigen, Tumor

Leading manufacturers include Beckman Coulter, Inc., Fujirebio Diagnostics,Inc. and Roche Diagnostics.

28
Total
28
Cleared
165d
Avg days
1997
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared System, Test, Immunological, Antigen, Tumor Devices (Product Code MOI)

28 devices
1–24 of 28
Cleared May 09, 2024
Access BR Monitor
K240403
Beckman Coulter, Inc.
Immunology · 90d
Cleared Mar 13, 2024
IMMULITE® 2000 BR-MA
K233946
Siemens Healthcare Diagnostics Products, Ltd.
Immunology · 90d
Cleared Sep 04, 2020
Lumipulse G CA15-3
K192524
Fujirebio Diagnostics,Inc.
Immunology · 357d
Cleared Feb 13, 2020
ADVIA Centaur BR
K193489
Siemens Healthcare Diagnostics, Inc.
Immunology · 58d
Cleared Nov 22, 2019
ADVIA Centaur CA 15-3 assay
K192777
Siemens Healthcare Diagnostics, Inc.
Immunology · 53d
Cleared Jun 22, 2018
Elecsys CA 15-3 II
K181492
Roche Diagnostics
Immunology · 16d
Cleared Feb 20, 2018
Elecsys CA 15-3 II
K171605
Roche Diagnostics
Immunology · 264d
Cleared Apr 18, 2011
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605
K100344
Siemens Healthcare Diagnostics
Immunology · 437d
Cleared Oct 26, 2007
ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647
K072612
Beckman Coulter, Inc.
Immunology · 39d
Cleared Dec 22, 2004
ARCHITECT CA 15-3 ASSAY
K042732
Fujirebio Diagnostics,Inc.
Immunology · 82d
Cleared Feb 03, 2004
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647
K033036
Beckman Coulter, Inc.
Immunology · 127d
Cleared Mar 28, 2002
IMMULITE BR-MA, MODEL #LKBR
K013984
Diagnostic Products Corp.
Immunology · 115d
Cleared Aug 16, 2001
AIA-PACK BRCA, ST AIA PACK BRCA
K010796
Tosoh Medics, Inc.
Immunology · 153d
Cleared Mar 28, 2001
ELECSYSCA 15-3 II ASSAY
K010588
Roche Diagnostics Corp.
Immunology · 29d
Cleared Oct 23, 2000
ELECSYS CA 15-3 TEST SYSTEM
K001468
Roche Diagnostics Corp.
Immunology · 166d
Cleared Feb 02, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK
K983690
Ortho-Clinical Diagnostics, Inc.
Immunology · 104d
Cleared Dec 01, 1997
THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K964703
Bayer Corp.
Immunology · 374d
Cleared Nov 10, 1997
IMX CA 15-3
K964407
Abbott Laboratories
Immunology · 371d
Cleared Sep 15, 1997
AXSYM CA 15-3
K963926
Abbott Laboratories
Immunology · 350d

About Product Code MOI - Regulatory Context

510(k) Submission Activity

28 total 510(k) submissions under product code MOI since 1997, with 28 receiving FDA clearance (average review time: 165 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.