Ca 125 II Assay for the Bayer Advia Integrated Module System
FDA 510(k) K022329 · Bayer Diagnostics Corp.
510(k) numberK022329
Submission
- Device name
- Ca 125 II Assay for the Bayer Advia Integrated Module System
- Applicant
- Bayer Diagnostics Corp.
Tarrytown, NY, US - Received
- July 18, 2002
- Decision date
- November 27, 2002
- 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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| 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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| K022177 | Prostate Specific Antigen (Psa) Assay for the Advia Integrated Modular SystemLTJ · Traditional | 12/17/2002SE |
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Questions and answers
When was Ca 125 II Assay for the Bayer Advia Integrated Module System cleared by the FDA?
Ca 125 II Assay for the Bayer Advia Integrated Module System (K022329) received a 510(k) decision of Substantially Equivalent on November 27, 2002, 132 days after the submission was received.
What is the product code of K022329?
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.