Vitros Immunodiagnostic Products Ca 125 II Calibrators, Vitros Immunodiagnostic Products Ca 125 II Reagent Pack
FDA 510(k) K983875 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK983875
Submission
- Device name
- Vitros Immunodiagnostic Products Ca 125 II Calibrators, Vitros Immunodiagnostic Products Ca 125 II Reagent Pack
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- November 2, 1998
- Decision date
- May 14, 1999
- 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
Other 510(k)s with product code LTK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240479 | Access OV MonitorLTK · Traditional | Beckman Coulter, Inc. | 05/10/2024SE |
| K213510 | Immulite/Immulite 1000 Om-Ma, Immulite 2000 Om-MaLTK · Traditional | Siemens Healthcare Diagnostics Products, Ltd. | 09/08/2023SE |
| 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 |
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| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA · Traditional | 05/08/2024SE |
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| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent PackNIG · Traditional | 08/09/2023SE |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK · Traditional | 12/12/2022SE |
| K213626 | Vitros AfpLOJ · Traditional | 06/15/2022SE |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent PackJHX · Traditional | 01/28/2022SE |
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Questions and answers
When was Vitros Immunodiagnostic Products Ca 125 II Calibrators, Vitros Immunodiagnostic Products Ca 125 II Reagent Pack cleared by the FDA?
Vitros Immunodiagnostic Products Ca 125 II Calibrators, Vitros Immunodiagnostic Products Ca 125 II Reagent Pack (K983875) received a 510(k) decision of Substantially Equivalent on May 14, 1999, 193 days after the submission was received.
What is the product code of K983875?
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.