FDA Product Code MOI: System, Test, Immunological, Antigen, Tumor
Leading manufacturers include Beckman Coulter, Inc., Roche Diagnostics Corp. 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
Cleared
May 09, 2024
Access BR Monitor
Beckman Coulter, Inc.
Immunology
90d
Cleared
Mar 13, 2024
IMMULITE® 2000 BR-MA
Siemens Healthcare Diagnostics Products, Ltd.
Immunology
90d
Cleared
Sep 04, 2020
Lumipulse G CA15-3
Fujirebio Diagnostics,Inc.
Immunology
357d
Cleared
Feb 13, 2020
ADVIA Centaur BR
Siemens Healthcare Diagnostics, Inc.
Immunology
58d
Cleared
Nov 22, 2019
ADVIA Centaur CA 15-3 assay
Siemens Healthcare Diagnostics, Inc.
Immunology
53d
Cleared
Jun 22, 2018
Elecsys CA 15-3 II
Roche Diagnostics
Immunology
16d
Cleared
Feb 20, 2018
Elecsys CA 15-3 II
Roche Diagnostics
Immunology
264d
Cleared
Oct 26, 2007
ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647
Beckman Coulter, Inc.
Immunology
39d
Cleared
Feb 03, 2004
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647
Beckman Coulter, Inc.
Immunology
127d
Cleared
Mar 28, 2002
IMMULITE BR-MA, MODEL #LKBR
Diagnostic Products Corp.
Immunology
115d
Cleared
Mar 28, 2001
ELECSYSCA 15-3 II ASSAY
Roche Diagnostics Corp.
Immunology
29d
Cleared
Oct 23, 2000
ELECSYS CA 15-3 TEST SYSTEM
Roche Diagnostics Corp.
Immunology
166d
Cleared
Nov 10, 1997
IMX CA 15-3
Abbott Laboratories
Immunology
371d
Cleared
Sep 15, 1997
AXSYM CA 15-3
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.