| Access BR Monitor (K240403) | Beckman Coulter, Inc. | 2024-05-09 |
| IMMULITE® 2000 BR-MA (K233946) | Siemens Healthcare Diagnostics Products, Ltd. | 2024-03-13 |
| Lumipulse G CA15-3 (K192524) | Fujirebio Diagnostics,Inc. | 2020-09-04 |
| ADVIA Centaur BR (K193489) | Siemens Healthcare Diagnostics, Inc. | 2020-02-13 |
| ADVIA Centaur CA 15-3 assay (K192777) | Siemens Healthcare Diagnostics, Inc. | 2019-11-22 |
| Elecsys CA 15-3 II (K181492) | Roche Diagnostics | 2018-06-22 |
| Elecsys CA 15-3 II (K171605) | Roche Diagnostics | 2018-02-20 |
| DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 (K100344) | Siemens Healthcare Diagnostics | 2011-04-18 |
| ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647 (K072612) | Beckman Coulter, Inc. | 2007-10-26 |
| ARCHITECT CA 15-3 ASSAY (K042732) | Fujirebio Diagnostics,Inc. | 2004-12-22 |
| BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 (K033036) | Beckman Coulter, Inc. | 2004-02-03 |
| CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022178) | Bayer Diagnostics Corp. | 2002-11-12 |
| IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR (K013984) | Diagnostic Products Corp. | 2002-03-28 |
| CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM (K012357) | Bayer Diagnostics Corp. | 2002-02-28 |
| AIA-PACK BRCA, ST AIA PACK BRCA (K010796) | Tosoh Medics, Inc. | 2001-08-16 |
| ELECSYSCA 15-3 II ASSAY (K010588) | Roche Diagnostics Corp. | 2001-03-28 |
| ELECSYS CA 15-3 TEST SYSTEM (K001468) | Roche Diagnostics Corp. | 2000-10-23 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK (K983690) | Ortho-Clinical Diagnostics, Inc. | 1999-02-02 |
| CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY (K982680) | Chiron Diagnostics Corp. | 1998-10-15 |
| ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) (K981698) | Chiron Corp. | 1998-07-10 |
| ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM) (K980190) | Chiron Corp. | 1998-03-06 |
| THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K964703) | Bayer Corp. | 1997-12-01 |
| IMX CA 15-3 (K964407) | Abbott Laboratories | 1997-11-10 |
| TRUQUANT BR RIA (K965141) | Biomira USA, Inc. | 1997-10-31 |
| AXSYM CA 15-3 (K963926) | Abbott Laboratories | 1997-09-15 |
| ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) (K970695) | Chiron Diagnostics Corp. | 1997-08-08 |
| CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER (K971418) | Chiron Diagnostics Corp. | 1997-07-17 |
| CENTOCOR CA 15-3 RIA MODEL NO. 800-033 (K963803) | Centocor, Inc. | 1997-05-23 |