Modified Ddi Serocard Toxoplasma Igg Test Kit
FDA 510(k) K884249 · Disease Detection International, Inc.
510(k) numberK884249
Submission
- Device name
- Modified Ddi Serocard Toxoplasma Igg Test Kit
- Applicant
- Disease Detection International, Inc.
Irvine, CA, US - Received
- October 11, 1988
- Decision date
- April 10, 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 |
|---|---|---|
| K943252 | Pro-Step LH Ovulation Prediction TestCEP · Traditional | 10/25/1994SE |
| K925303 | Pro-Step PT HCGJHI · Traditional | 06/15/1993SE |
| K925125 | Pro-Step HCGJHI · Traditional | 01/13/1993SE |
| K911826 | Immunocard HCG One Step (I-S) Test KitJHI · Traditional | 07/19/1991SE |
| K902571 | Modification of Serocard Rubella Igg TestLFX · Traditional | 09/05/1990SE |
| K903070 | Serocard HSV Igg Antibody Test KitLGC · Traditional | 08/09/1990SE |
| K895912 | Immunocard HCG Ii-S Test KitJHI · Traditional | 12/01/1989SE |
| K896109 | Immunocard Strep a TestGTZ · Traditional | 11/29/1989SE |
| K884248 | Modified Ddi Serocard CMV Igg Test KitLFZ · Traditional | 04/10/1989SE |
| K884247 | Modified Ddi Serocard Rubella Igg Test KitLFX · Traditional | 04/10/1989SE |
Questions and answers
When was Modified Ddi Serocard Toxoplasma Igg Test Kit cleared by the FDA?
Modified Ddi Serocard Toxoplasma Igg Test Kit (K884249) received a 510(k) decision of Substantially Equivalent on April 10, 1989, 181 days after the submission was received.
What is the product code of K884249?
The FDA product code is LGD – Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.