FDA 510(k) Applications for Medical Device Product Code "MOI"
(System, Test, Immunological, Antigen, Tumor)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K963926 | ABBOTT LABORATORIES | AXSYM CA 15-3 | 09/15/1997 |
| K964407 | ABBOTT LABORATORIES | IMX CA 15-3 | 11/10/1997 |
| K964703 | BAYER CORP. | THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | 12/01/1997 |
| K012357 | BAYER DIAGNOSTICS CORP. | CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM | 02/28/2002 |
| K022178 | BAYER DIAGNOSTICS CORP. | CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | 11/12/2002 |
| K072612 | BECKMAN COULTER, INC. | ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647 | 10/26/2007 |
| K033036 | BECKMAN COULTER, INC. | BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 | 02/03/2004 |
| K965141 | BIOMIRA USA, INC. | TRUQUANT BR RIA | 10/31/1997 |
| K963803 | CENTOCOR, INC. | CENTOCOR CA 15-3 RIA MODEL NO. 800-033 | 05/23/1997 |
| K980190 | CHIRON CORP. | ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM) | 03/06/1998 |
| K981698 | CHIRON CORP. | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) | 07/10/1998 |
| K970695 | CHIRON DIAGNOSTICS CORP. | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) | 08/08/1997 |
| K971418 | CHIRON DIAGNOSTICS CORP. | CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER | 07/17/1997 |
| K982680 | CHIRON DIAGNOSTICS CORP. | CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY | 10/15/1998 |
| K013984 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR | 03/28/2002 |
| K042732 | FUJIREBIO DIAGNOSTICS, INC. | ARCHITECT CA 15-3 ASSAY | 12/22/2004 |
| K192524 | Fujirebio Diagnostics, Inc. | Lumipulse G CA15-3 | 09/04/2020 |
| K983690 | Ortho-Clinical Diagnostics, Inc. | VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK | 02/02/1999 |
| K171605 | Roche Diagnostics | Elecsys CA 15-3 II | 02/20/2018 |
| K181492 | Roche Diagnostics | Elecsys CA 15-3 II | 06/22/2018 |
| K001468 | ROCHE DIAGNOSTICS CORP. | ELECSYS CA 15-3 TEST SYSTEM | 10/23/2000 |
| K010588 | ROCHE DIAGNOSTICS CORP. | ELECSYSCA 15-3 II ASSAY | 03/28/2001 |
| K100344 | SIEMENS HEALTHCARE DIAGNOSTICS | DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 | 04/18/2011 |
| K193489 | Siemens Healthcare Diagnostics Inc. | ADVIA Centaur BR | 02/13/2020 |
| K192777 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur CA 15-3 assay | 11/22/2019 |
| K010796 | TOSOH MEDICS, INC. | AIA-PACK BRCA, ST AIA PACK BRCA | 08/16/2001 |
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