Immulite/Immulite 1000 Om-Ma, Immulite 2000 Om-Ma
FDA 510(k) K213510 · Siemens Healthcare Diagnostics Products, Ltd.
510(k) numberK213510
Submission
- Device name
- Immulite/Immulite 1000 Om-Ma, Immulite 2000 Om-Ma
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
Llanberis, GB - Received
- November 2, 2021
- Decision date
- September 8, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LTK – Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Specialty
- Immunology
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|---|---|---|---|
| K240479 | Access OV MonitorLTK · Traditional | Beckman Coulter, Inc. | 05/10/2024SE |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK · Traditional | Ortho Clinical Diagnostics | 12/12/2022SE |
| K200199 | ADVIA Centaur CA 125IILTK · Traditional | Siemens Healthcare Diagnostics, Inc. | 04/06/2020SE |
| K143534 | Elecsys CA-125 II assayLTK · Traditional | Roche Professional Diagnostics | 08/06/2015SE |
| K142895 | LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA…LTK · Traditional | Fujirebio Diagnostics,Inc. | 05/21/2015SE |
| K100321 | Dimension Vista Loci Ca 125 Flex Reagent Cartridge,And Dimensions Vista Loci 6 Cal…LTK · Traditional | Siemens Healthcare Diagnostics | 04/12/2011SE |
| K080469 | Vidas Ca 15-3 AssayLTK · Traditional | bioMerieux, Inc. | 06/22/2009SE |
| K080561 | Vidas Ca 125 II AssayLTK · Traditional | bioMerieux, Inc. | 04/10/2009SE |
| K072794 | Immulite 2500 Om-Ma, Model L5KOPLTK · Special | Siemens Medical Solutions Diagnostics | 11/05/2007SE |
| K042731 | Architect Ca 125 II AssayLTK · Traditional | Fujirebio Diagnostics,Inc. | 11/19/2004SE |
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Questions and answers
When was Immulite/Immulite 1000 Om-Ma, Immulite 2000 Om-Ma cleared by the FDA?
Immulite/Immulite 1000 Om-Ma, Immulite 2000 Om-Ma (K213510) received a 510(k) decision of Substantially Equivalent on September 8, 2023, 675 days after the submission was received.
What is the product code of K213510?
The FDA product code is LTK – Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125), a Class II (moderate risk) device regulated under 21 CFR 866.6010.