Ige, Peroxidase, Antigen, Antiserum, Control
FDA product code DGO · Class II (moderate risk) · 21 CFR 866.5510 · Immunology
15510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K943194 | Immulite(R) Allergy Food Panel FP5EDGO · Traditional | Diagnostic Products Corp. | 02/23/1995SE |
| K920087 | Ige Eia Test KitDGO · Traditional | The Binding Site, Ltd. | 09/14/1992SE |
| K911511 | Alastat Allergen Specified Ige System, ModifiedDGO · Traditional | Diagnostic Products Corp. | 04/17/1991SE |
| K894039 | Quidel Total Ige Test Quantitative VersionDGO · Traditional | Quidel Corp. | 07/14/1989SE |
| K893125 | Beckman Epsilon(Tm) Ige Reagent KitDGO · Traditional | Beckman Instruments, Inc. | 06/16/1989SE |
| K872801 | Alleia Total Ige Eia W/Mono Anti. EKIE1, 2, 5DGO · Traditional | Diagnostic Products Corp. | 09/10/1987SE |
| K860851 | Allegro Ige Enzyme Immunoassay SystemDGO · Traditional | Nichols Institute Diagnostics | 03/28/1986SE |
| K853607 | Allerg-E Ige Enzyme Immunoassay KitDGO · Traditional | Dexall Biomedical Labs, Inc. | 11/07/1985SE |
| K831984 | Polystyrene Micro-Liter Plate-BirchtreeDGO · Traditional | Diagnostic Reagent Tech. | 11/21/1983SE |
| K831987 | Epsilon Ige Test KitDGO · Traditional | Beckman Instruments, Inc. | 10/14/1983SE |
| K831774 | Logipe a Data Reducsystem Ip Specific-DGO · Traditional | Diagnostic Reagent Tech. | 07/18/1983SE |
| K830653 | Polystyrene Microtiter Plate ImmunosorbDGO · Traditional | Diagnostic Reagent Tech. | 04/08/1983SE |
| K830495 | Polystyrene Microtiter Plate ImmunosorDGO · Traditional | Diagnostic Reagent Tech. | 04/05/1983SE |
| K821094 | Ip Specific EDGO · Traditional | Diagnostic Reagent Tech. | 05/07/1982SE |
| K800995 | Immunoglobulin E Test KitDGO · Traditional | Calbiochem-Behring Corp. | 05/14/1980SE |