Toxostat M Test Kit
FDA 510(k) K875113 · Whittaker Bioproducts, Inc.
510(k) numberK875113
Submission
- Device name
- Toxostat M Test Kit
- Applicant
- Whittaker Bioproducts, Inc.
Walkersville, MD, US - Received
- December 15, 1987
- Decision date
- April 12, 1988
- 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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| 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 |
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| 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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|---|---|---|
| K911356 | Legionella Stat Igg/Igm Test KitMJH · Traditional | 07/30/1992SE |
| K913212 | 3M Ige Single Point Fast TestDHB · Traditional | 11/22/1991SE |
| K904652 | Lyme Stat M Test KitLSR · Traditional | 10/21/1991SE |
| K904893 | Fiax Lyme M Test KitLSR · Traditional | 10/16/1991SE |
| K911473 | Ebna Stat Test KitLLM · Traditional | 09/25/1991SE |
| K905468 | Pylori-G Fiax Test KitLYR · Traditional | 05/07/1991SE |
| K904738 | Pylori Stat Test KitLYR · Traditional | 05/07/1991SE |
| K901493 | Fitc Murine Monoclonal Anti-Influenza Type BGNX · Traditional | 06/27/1990SE |
| K893579 | Fitc Murine Monoclonal Anti-Influenza Type aGNX · Traditional | 01/16/1990SE |
| K894932 | Fiax Eb Vca-M Test KitLSE · Traditional | 10/16/1989SE |
Questions and answers
When was Toxostat M Test Kit cleared by the FDA?
Toxostat M Test Kit (K875113) received a 510(k) decision of Substantially Equivalent on April 12, 1988, 119 days after the submission was received.
What is the product code of K875113?
The FDA product code is LGD – Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.