FDA Product Code
FDA Product Code LTK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.6010
510(k) Clearances — 26 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240479 | Access OV Monitor | Beckman Coulter, Inc. | 2024-05-10 | Traditional | PDF ↗ |
| K213510 | IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA | Siemens Healthcare Diagnostics Products, Ltd. | 2023-09-08 | Traditional | PDF ↗ |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent Pack | Ortho Clinical Diagnostics | 2022-12-12 | Traditional | PDF ↗ |
| K200199 | ADVIA Centaur CA 125II | Siemens Healthcare Diagnostics, Inc. | 2020-04-06 | Traditional | PDF ↗ |
| K143534 | Elecsys CA-125 II assay | Roche Professional Diagnostics | 2015-08-06 | Traditional | PDF ↗ |
| K142895 | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators | Fujirebio Diagnostics,Inc. | 2015-05-21 | Traditional | PDF ↗ |
| K100321 | DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604 | Siemens Healthcare Diagnostics | 2011-04-12 | Traditional | PDF ↗ |
| K080469 | VIDAS CA 15-3 ASSAY | bioMerieux, Inc. | 2009-06-22 | Traditional | PDF ↗ |
| K080561 | VIDAS CA 125 II ASSAY | bioMerieux, Inc. | 2009-04-10 | Traditional | PDF ↗ |
| K072794 | IMMULITE 2500 OM-MA, MODEL L5KOP | Siemens Medical Solutions Diagnostics | 2007-11-05 | Special | PDF ↗ |
| K042731 | ARCHITECT CA 125 II ASSAY | Fujirebio Diagnostics,Inc. | 2004-11-19 | Traditional | PDF ↗ |
| K031297 | ACCESS OV MONITOR ASSAY | Beckman Coulter, Inc. | 2003-05-02 | Special | PDF ↗ |
| K023597 | ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY | Beckman Coulter, Inc. | 2002-12-11 | Traditional | PDF ↗ |
| K023891 | ST AIA-PACK CA 125 ENZYME IMMUNOASSAY | Tosoh Medics, Inc. | 2002-12-06 | Special | PDF ↗ |
| K022329 | CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | Bayer Diagnostics Corp. | 2002-11-27 | Traditional | PDF ↗ |
| K020828 | CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM | Bayer Corp. | 2002-07-24 | Traditional | PDF ↗ |
| K990431 | AIA-PACK CA 125 | Tosoh Medics, Inc. | 1999-06-03 | Traditional | PDF ↗ |
| K983875 | VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK | Ortho-Clinical Diagnostics, Inc. | 1999-05-14 | Traditional | PDF ↗ |
| K983715 | THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | 1999-05-14 | Traditional | PDF ↗ |
| K983391 | IMMULITE 2000 OM-MA MODEL L2KOP2 | Diagnostic Products Corp. | 1998-10-15 | Traditional | PDF ↗ |
| K981297 | IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 | Diagnostic Products Corp. | 1998-09-18 | Traditional | PDF ↗ |
| K980240 | ELECSYS CA 125II ON THE ELECSYS 1010 | Boehringer Mannheim Corp. | 1998-03-25 | Traditional | PDF ↗ |
| K972162 | ELECSYS CA 125 II | Boehringer Mannheim Corp. | 1998-03-18 | Traditional | PDF ↗ |
| K964185 | IMX CA 125 | Abbott Diagnostics | 1997-11-04 | Traditional | PDF ↗ |
| K964020 | AXSYM CA 125 | Abbott Laboratories | 1997-11-04 | Traditional | PDF ↗ |
| K964098 | CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM | Bayer Corp. | 1997-10-31 | Traditional | PDF ↗ |
Product code LTK · Class II · Immunology. Data: openFDA.