Modified Labysystems' Toxoplasma Gondii Igg Eia
FDA 510(k) K890154 · Labsystems, Inc.
510(k) numberK890154
Submission
- Device name
- Modified Labysystems' Toxoplasma Gondii Igg Eia
- Applicant
- Labsystems, Inc.
Finland, FI - Received
- January 12, 1989
- Decision date
- February 7, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
More from Siemens Healthcare Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K923365 | Tilt/Reduced Shear Semi-Recline Seating SystemITI · Traditional | 03/24/1993SE |
| K896474 | Resubmitted Fecatwin Sensitive - Feca-EiaKHE · Traditional | 01/25/1990SE |
| K890091 | Modified Labsystems' Rubella Igg Eia Test KitLFX · Traditional | 02/03/1989SE |
| K881243 | Rubella Igg - Eia Test Kit Number 61 07 201LFX · Traditional | 04/04/1988SE |
| K873780 | Modification Rubella Igm Eia Test KitLFX · Traditional | 10/15/1987SE |
| K873583 | Auto-EiaJJQ · Traditional | 09/22/1987SE |
| K872252 | Modified Toxoplasma Gondii Igg Eia Test KitLGD · Traditional | 07/01/1987SE |
| K862705 | Cytomegalovirus Igg Eia Test KitGQI · Traditional | 10/01/1986SE |
| K862431 | Rubella Igm Eia Test KitLFX · Traditional | 08/08/1986SE |
| K862216 | Toxoplasma Gondii Igg Eia Test Kit (Amendment)LGD · Traditional | 06/30/1986SE |
Questions and answers
When was Modified Labysystems' Toxoplasma Gondii Igg Eia cleared by the FDA?
Modified Labysystems' Toxoplasma Gondii Igg Eia (K890154) received a 510(k) decision of Substantially Equivalent on February 7, 1989, 26 days after the submission was received.
What is the product code of K890154?
The FDA product code is LGD – Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.