FDA 510(k) Applications for Medical Device Product Code "LTK"
(Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K964185 | ABBOTT DIAGNOSTICS | IMX CA 125 | 11/04/1997 |
| K964020 | ABBOTT LABORATORIES | AXSYM CA 125 | 11/04/1997 |
| K020828 | BAYER CORP. | CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM | 07/24/2002 |
| K964098 | BAYER CORP. | CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | 10/31/1997 |
| K983715 | BAYER CORP. | THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | 05/14/1999 |
| K022329 | BAYER DIAGNOSTICS CORP. | CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | 11/27/2002 |
| K031297 | BECKMAN COULTER, INC. | ACCESS OV MONITOR ASSAY | 05/02/2003 |
| K023597 | BECKMAN COULTER, INC. | ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY | 12/11/2002 |
| K080561 | BIOMERIEUX, INC. | VIDAS CA 125 II ASSAY | 04/10/2009 |
| K080469 | BIOMERIEUX, INC. | VIDAS CA 15-3 ASSAY | 06/22/2009 |
| K972162 | BOEHRINGER MANNHEIM CORP. | ELECSYS CA 125 II | 03/18/1998 |
| K980240 | BOEHRINGER MANNHEIM CORP. | ELECSYS CA 125II ON THE ELECSYS 1010 | 03/25/1998 |
| K983391 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE 2000 OM-MA MODEL L2KOP2 | 10/15/1998 |
| K981297 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 | 09/18/1998 |
| K142895 | FUJIREBIO DIAGNOSTICS, INC | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators | 05/21/2015 |
| K042731 | FUJIREBIO DIAGNOSTICS, INC. | ARCHITECT CA 125 II ASSAY | 11/19/2004 |
| K221355 | Ortho Clinical Diagnostics | VITROS Immuodiagnostic Products CA 125 II Reagent Pack | 12/12/2022 |
| K983875 | Ortho-Clinical Diagnostics, Inc. | VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK | 05/14/1999 |
| K143534 | ROCHE PROFESSIONAL DIAGNOSTICS | Elecsys CA-125 II assay | 08/06/2015 |
| K100321 | SIEMENS HEALTHCARE DIAGNOSTICS | DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604 | 04/12/2011 |
| K213510 | Siemens Healthcare Diagnostics Products Ltd | IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA | 09/08/2023 |
| K200199 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur CA 125II | 04/06/2020 |
| K072794 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS | IMMULITE 2500 OM-MA, MODEL L5KOP | 11/05/2007 |
| K990431 | TOSOH MEDICS, INC. | AIA-PACK CA 125 | 06/03/1999 |
| K023891 | TOSOH MEDICS, INC. | ST AIA-PACK CA 125 ENZYME IMMUNOASSAY | 12/06/2002 |
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