Polystyrene Microtiter Plate Immunosorb
FDA 510(k) K830653 · Diagnostic Reagent Tech.
510(k) numberK830653
Submission
- Device name
- Polystyrene Microtiter Plate Immunosorb
- Applicant
- Diagnostic Reagent Tech.
Mchenry, IL, US - Received
- March 1, 1983
- Decision date
- April 8, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DGO – Ige, Peroxidase, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code DGO
| 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 |
More from Beckman Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K843302 | New Allerg. Coated Microfilter Well StriDHB · Traditional | 10/04/1984SE |
| K832345 | Polystyrene Microtiter Well ImmunosorDGC · Traditional | 11/25/1983SE |
| K832344 | Polystyrene Microtiter Plate Immuno-DHB · Traditional | 11/21/1983SE |
| K831984 | Polystyrene Micro-Liter Plate-BirchtreeDGO · Traditional | 11/21/1983SE |
| K831496 | Allergen Immunosorbents Ip Specific E · Traditional | 08/08/1983SE |
| K831774 | Logipe a Data Reducsystem Ip Specific-DGO · Traditional | 07/18/1983SE |
| K830005 | Ip Specific GDAA · Traditional | 06/02/1983SE |
| K830495 | Polystyrene Microtiter Plate ImmunosorDGO · Traditional | 04/05/1983SE |
| K821094 | Ip Specific EDGO · Traditional | 05/07/1982SE |
Questions and answers
When was Polystyrene Microtiter Plate Immunosorb cleared by the FDA?
Polystyrene Microtiter Plate Immunosorb (K830653) received a 510(k) decision of Substantially Equivalent on April 8, 1983, 38 days after the submission was received.
What is the product code of K830653?
The FDA product code is DGO – Ige, Peroxidase, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.