ADVIA Centaur Toxoplasma M (Toxo M)
FDA 510(k) K142826 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK142826
Submission
- Device name
- ADVIA Centaur Toxoplasma M (Toxo M)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY, US - Received
- September 30, 2014
- Decision date
- December 22, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LGD – Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3780
- Specialty
- Microbiology
Other 510(k)s with product code LGD
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|---|---|---|---|
| K242022 | Access Toxo IgGLGD · Traditional | Beckman Coulter, Inc. | 03/28/2025SE |
| K242095 | Access Toxo IgM IILGD · Traditional | Beckman Coulter, Inc. | 10/11/2024SE |
| K233932 | Alinity i Toxo IgMLGD · Traditional | Abbott Laboratories | 08/30/2024SE |
| K210596 | ARCHITECT Toxo IgGLGD · Traditional | Abbott Laboratories | 05/19/2022SE |
| K162678 | Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlLGD · Traditional | Roche Diagnostics | 06/23/2017SE |
| K132234 | Liaison(R) Toxo Igg II, Liaison(R) Control Toxo Igg IILGD · Traditional | DiaSorin, Inc. | 08/28/2013SE |
| K131441 | Liaison Toxo Igm II, Liaison Control Toxo Igm IILGD · Traditional | DiaSorin, Inc. | 08/09/2013SE |
| K101946 | Vidas Toxo Igg AvidityLGD · Traditional | bioMerieux, Inc. | 05/18/2011SE |
| K102681 | Advia Centaur Toxoplasma Igg (Toxo G)LGD · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/04/2011SE |
| K090847 | Platelia Toxo Igm Kit Model 26211LGD · Special | Bio-Rad Laboratories | 07/01/2009SE |
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Questions and answers
When was ADVIA Centaur Toxoplasma M (Toxo M) cleared by the FDA?
ADVIA Centaur Toxoplasma M (Toxo M) (K142826) received a 510(k) decision of Substantially Equivalent on December 22, 2015, 448 days after the submission was received.
What is the product code of K142826?
The FDA product code is LGD – Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.