Gold Standard Diagnostics
Medical device manufacturer in Davis, CA.
15510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGMQ · Traditional | 10/10/2025SE |
| K203296 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitLSR · Traditional | 03/22/2021SE |
| K203295 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitLSR · Traditional | 03/22/2021SE |
| K203292 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitLSR · Traditional | 03/22/2021SE |
| K203289 | Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test KitLSR · Traditional | 03/22/2021SE |
| K200025 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test KitLSR · Traditional | 04/06/2020SE |
| K200023 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test KitLSR · Traditional | 04/06/2020SE |
| K180264 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test KitLSR · Traditional | 05/02/2018SE |
| K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test SystemGMQ · Traditional | 11/12/2015SE |
| K131334 | Herpes Simplex Virus Type 1 Igg Elisa TestMXJ · Traditional | 02/28/2014SE |
| K131330 | Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test KitLJM · Traditional | 01/28/2014SE |
| K113846 | Borrelia Burgdorferi Igm Blot TestLSR · Traditional | 06/01/2012SE |
| K113847 | Borrelia Burgdorferi Igg Blot TestLSR · Traditional | 04/11/2012SE |
| K110745 | Helicobacter Pylori Elisa Igg Test KitLYR · Traditional | 03/02/2012SE |
| K110899 | Gold Standard Diagnostics H. Pylori Elisa Iga Test KitLYR · Traditional | 02/01/2012SE |