Livonia Diagnostics, Inc.
Medical device manufacturer in Livonia, MI.
16510(k) clearances
0PMA approvals
0recalls
Device types
- GHM Test, Sickle Cell 1
- CHH Enzymatic Esterase--Oxidase, Cholesterol 1
- CGA Glucose Oxidase, Glucose 1
- CEK Biuret (Colorimetric), Total Protein 1
- CIX Bromcresol Green Dye-Binding, Albumin 1
- JGJ Photometric Method, Magnesium 1
- CIC Cresolphthalein Complexone, Calcium 1
- CGX Alkaline Picrate, Colorimetry, Creatinine 1
- LFQ Acid, Uric, Acid Reduction Of Ferric Ion 1
- LBR Ldl & Vldl Precipitation, Hdl 1
- CEO Phosphomolybdate (Colorimetric), Inorganic… 1
- CDW Diacetyl-Monoxime, Urea Nitrogen 1
- CIO Thymolphthalein Monophosphate, Alkaline… 1
- CKD Hydrazone Colorimetry, Alt/Sgpt 1
- CIQ Diazo, Ast/Sgot 1
- JIY Photometric Method, Iron (Non-Heme) 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K852161 | Serum Iron/Vibc Reagent SetJIY · Traditional | 06/10/1985SE |
| K844322 | Sgot Reagent SetCIQ · Traditional | 11/27/1984SE |
| K844283 | SGPT Reagent SetCKD · Traditional | 11/27/1984SE |
| K844237 | Alkaline Phosphatase Reagent SetCIO · Traditional | 11/20/1984SE |
| K844156 | Urea Nitrogen Reagent SetCDW · Traditional | 11/13/1984SE |
| K844182 | Inorganic Phosphorus Reagent SetCEO · Traditional | 11/09/1984SE |
| K843894 | HDL Precipatating Reagent SetLBR · Traditional | 11/02/1984SE |
| K844075 | Uric Acid Reagent SetLFQ · Traditional | 10/30/1984SE |
| K844024 | Creatinine Reagent SetCGX · Traditional | 10/30/1984SE |
| K843895 | Total Calcium Reagent SetCIC · Traditional | 10/30/1984SE |
| K843893 | Magnesium Reagent SetJGJ · Traditional | 10/30/1984SE |
| K843831 | Albumin Reagent SetCIX · Traditional | 10/11/1984SE |
| K843701 | Total Protein Reagent SetCEK · Traditional | 10/01/1984SE |
| K843528 | Glucose Oxidase Enzymatic Reagent SetCGA · Traditional | 09/28/1984SE |
| K843222 | Enzymatic Cholesterol KitCHH · Traditional | 09/28/1984SE |
| K842368 | Sickle Cell Reagent SetGHM · Traditional | 07/20/1984SE |