LTK — Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) Class II
FDA product code LTK covers "Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)", a Class II medical device regulated under 21 CFR 866.6010. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LTK
- Device Class
- Class II
- Regulation Number
- 866.6010
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240479 | beckman coulter | Access OV Monitor | May 10, 2024 |
| K213510 | siemens healthcare diagnostics products | IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA | September 8, 2023 |
| K221355 | ortho clinical diagnostics | VITROS Immuodiagnostic Products CA 125 II Reagent Pack | December 12, 2022 |
| K200199 | siemens healthcare diagnostics | ADVIA Centaur CA 125II | April 6, 2020 |
| K143534 | roche professional diagnostics | Elecsys CA-125 II assay | August 6, 2015 |
| K142895 | fujirebio diagnostics | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULS | May 21, 2015 |
| K100321 | siemens healthcare diagnostics | DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 C | April 12, 2011 |
| K080469 | biomerieux | VIDAS CA 15-3 ASSAY | June 22, 2009 |
| K080561 | biomerieux | VIDAS CA 125 II ASSAY | April 10, 2009 |
| K072794 | siemens medical solutions diagnostics | IMMULITE 2500 OM-MA, MODEL L5KOP | November 5, 2007 |
| K042731 | fujirebio diagnostics | ARCHITECT CA 125 II ASSAY | November 19, 2004 |
| K031297 | beckman coulter | ACCESS OV MONITOR ASSAY | May 2, 2003 |
| K023597 | beckman coulter | ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY | December 11, 2002 |
| K023891 | tosoh medics | ST AIA-PACK CA 125 ENZYME IMMUNOASSAY | December 6, 2002 |
| K022329 | bayer diagnostics | CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | November 27, 2002 |
| K020828 | bayer | CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM | July 24, 2002 |
| K990431 | tosoh medics | AIA-PACK CA 125 | June 3, 1999 |
| K983875 | ortho-clinical diagnostics | VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC | May 14, 1999 |
| K983715 | bayer | THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC | May 14, 1999 |
| K983391 | diagnostic products | IMMULITE 2000 OM-MA MODEL L2KOP2 | October 15, 1998 |