Toxoplasma Igg Clin-Elisa Test Kit Cat. No. 4560
FDA 510(k) K860773 · Clinical Sciences, Inc.
510(k) numberK860773
Submission
- Device name
- Toxoplasma Igg Clin-Elisa Test Kit Cat. No. 4560
- Applicant
- Clinical Sciences, Inc.
Whippany, NJ, US - Received
- March 3, 1986
- Decision date
- May 23, 1986
- 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
Other 510(k)s with product code LGD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K900688 | Varicella Zoster Igg Clin-Elisa Test KitLFY · Traditional | 05/15/1990SE |
| K883871 | Epstein-Barr Viral Capsid Antigen Igm #5590LSE · Traditional | 07/14/1989SE |
| K883870 | Epstein-Barr Viral Capsid Antigen Igg #4590LSE · Traditional | 07/14/1989SE |
| K891990 | Rubeola Igg Clin-Elisa Test System, Cat. #4600LJB · Traditional | 06/15/1989SE |
| K883601 | Epstein-Barr Virus (EBNA-1) Igm Cata. #5550LLM · Traditional | 05/11/1989SE |
| K883600 | Epstein-Barr Virus (EBNA-1) Igg Cata. #4550LLM · Traditional | 05/11/1989SE |
| K874594 | Toxoplasma Igm Clin-Elisa(Tm) Cat # 5560LGD · Traditional | 03/07/1988SE |
| K872942 | Igm CMV Clin-Elisa(Tm) Test System Number: 5530LKQ · Traditional | 01/11/1988SE |
| K860145 | Rubella Elisa Test System Catalog Number: 4540LFX · Traditional | 07/14/1986SE |
| K854666 | Cytomegalovirus (CMV) Elisa Test Sys. Cat. NO:4530GQI · Traditional | 02/05/1986SE |
Questions and answers
When was Toxoplasma Igg Clin-Elisa Test Kit Cat. No. 4560 cleared by the FDA?
Toxoplasma Igg Clin-Elisa Test Kit Cat. No. 4560 (K860773) received a 510(k) decision of Substantially Equivalent on May 23, 1986, 81 days after the submission was received.
What is the product code of K860773?
The FDA product code is LGD – Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.