Aia-Pack Ca 125
FDA 510(k) K990431 · Tosoh Medics, Inc.
510(k) numberK990431
Submission
- Device name
- Aia-Pack Ca 125
- Applicant
- Tosoh Medics, Inc.
South San Francisco, CA, US - Received
- February 11, 1999
- Decision date
- June 3, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
More from Siemens Medical Solutions Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K023893 | ST Aia-Pack Cea Enzyme ImmunoassayDHX · Special | 12/18/2002SE |
| K023894 | ST Aia-Pack Afp Enzyme ImmunoassayLOJ · Special | 12/17/2002SE |
| K023091 | ST Aia-Pack Testosterone AssayCDZ · Traditional | 12/17/2002SE |
| K023891 | ST Aia-Pack Ca 125 Enzyme ImmunoassayLTK · Special | 12/06/2002SE |
| K020489 | G7 Automated HPLC Analyzer, Beta-Thalassemia ModeJPD · Traditional | 05/14/2002SE |
| K012820 | Aia-Pack Ctni 2ND-GEN AssayMMI · Traditional | 12/14/2001SE |
| K011434 | G7 Automated HPLC AnalyzerLCP · Traditional | 09/18/2001SE |
| K010796 | Aia-Pack Brca, ST Aia Pack BrcaMOI · Traditional | 08/16/2001SE |
| K992365 | Aia-Pack Folate AssayCGN · Traditional | 08/10/1999SE |
| K991252 | Aia-Pack FT3 AssayCDP · Traditional | 05/11/1999SE |
Questions and answers
When was Aia-Pack Ca 125 cleared by the FDA?
Aia-Pack Ca 125 (K990431) received a 510(k) decision of Substantially Equivalent on June 3, 1999, 112 days after the submission was received.
What is the product code of K990431?
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.