Panels › Immunology › Product code LTK · Class 2
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Regulation 866.6010
0510(k)s in 12 months (26 all time)
0recalls in 12 months (13 all time)
11recalls that name a 510(k)
Top companies in LTK
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 10, 2024 | K240479 | Access OV Monitor Beckman Coulter, Inc. | LTK |
| Sep 8, 2023 | K213510 | IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA Siemens Healthcare Diagnostics Products, Ltd., GB | LTK |
| Dec 12, 2022 | K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent Pack Ortho Clinical Diagnostics, GB | LTK |
| Apr 6, 2020 | K200199 | ADVIA Centaur CA 125II Siemens Healthcare Diagnostics, Inc. | LTK |
| Aug 6, 2015 | K143534 | Elecsys CA-125 II assay Roche Professional Diagnostics | LTK |
| May 21, 2015 | K142895 | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators Fujirebio Diagnostics,Inc. | LTK |
| Apr 12, 2011 | K100321 | DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604 Siemens Healthcare Diagnostics | LTK |
| Jun 22, 2009 | K080469 | VIDAS CA 15-3 ASSAY bioMerieux, Inc. | LTK |
| Apr 10, 2009 | K080561 | VIDAS CA 125 II ASSAY bioMerieux, Inc. | LTK |
| Nov 5, 2007 | K072794 | IMMULITE 2500 OM-MA, MODEL L5KOP Siemens Medical Solutions Diagnostics | LTK |
| Nov 19, 2004 | K042731 | ARCHITECT CA 125 II ASSAY Fujirebio Diagnostics,Inc. | LTK |
| May 2, 2003 | K031297 | ACCESS OV MONITOR ASSAY Beckman Coulter, Inc. | LTK |
| Dec 11, 2002 | K023597 | ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY Beckman Coulter, Inc. | LTK |
| Dec 6, 2002 | K023891 | ST AIA-PACK CA 125 ENZYME IMMUNOASSAY Tosoh Medics, Inc. | LTK |
| Nov 27, 2002 | K022329 | CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM Bayer Diagnostics Corp. | LTK |
| Jul 24, 2002 | K020828 | CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM Bayer Corp. | LTK |
| Jun 3, 1999 | K990431 | AIA-PACK CA 125 Tosoh Medics, Inc. | LTK |
| May 14, 1999 | K983875 | VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK Ortho-Clinical Diagnostics, Inc. | LTK |
| May 14, 1999 | K983715 | THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) Bayer Corp. | LTK |
| Oct 15, 1998 | K983391 | IMMULITE 2000 OM-MA MODEL L2KOP2 Diagnostic Products Corp. | LTK |
| Sep 18, 1998 | K981297 | IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 Diagnostic Products Corp. | LTK |
| Mar 25, 1998 | K980240 | ELECSYS CA 125II ON THE ELECSYS 1010 Boehringer Mannheim Corp. | LTK |
| Mar 18, 1998 | K972162 | ELECSYS CA 125 II Boehringer Mannheim Corp. | LTK |
| Nov 4, 1997 | K964185 | IMX CA 125 Abbott Diagnostics | LTK |
| Nov 4, 1997 | K964020 | AXSYM CA 125 Abbott Laboratories | LTK |
| Oct 31, 1997 | K964098 | CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM Bayer Corp. | LTK |
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