Immulite Toxoplasma Igm, Model LKTM1 and LKTM2, Immulite 2000 Toxoplasma Igm, Model L2KTM2 and L2KTM6
FDA 510(k) K012075 · Diagnostic Products Corp.
510(k) numberK012075
Submission
- Device name
- Immulite Toxoplasma Igm, Model LKTM1 and LKTM2, Immulite 2000 Toxoplasma Igm, Model L2KTM2 and L2KTM6
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- July 2, 2001
- Decision date
- January 10, 2002
- 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
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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 |
| K142826 | ADVIA Centaur Toxoplasma M (Toxo M)LGD · Traditional | Siemens Healthcare Diagnostics, Inc. | 12/22/2015SE |
| 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 |
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Questions and answers
When was Immulite Toxoplasma Igm, Model LKTM1 and LKTM2, Immulite 2000 Toxoplasma Igm, Model L2KTM2 and L2KTM6 cleared by the FDA?
Immulite Toxoplasma Igm, Model LKTM1 and LKTM2, Immulite 2000 Toxoplasma Igm, Model L2KTM2 and L2KTM6 (K012075) received a 510(k) decision of Substantially Equivalent on January 10, 2002, 192 days after the submission was received.
What is the product code of K012075?
The FDA product code is LGD – Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.