DGO — Ige, Peroxidase, Antigen, Antiserum, Control Class II
FDA product code DGO covers "Ige, Peroxidase, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5510. Submissions are reviewed by the Immunology panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DGO
- Device Class
- Class II
- Regulation Number
- 866.5510
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K943194 | Diagnostic Products | IMMULITE(R) ALLERGY FOOD PANEL FP5E | Feb 23, 1995 |
| K920087 | Binding Site | IGE EIA TEST KIT | Sep 14, 1992 |
| K911511 | Diagnostic Products | ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED | Apr 17, 1991 |
| K894039 | Quidel | QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION | Jul 14, 1989 |
| K893125 | Beckman Instruments | BECKMAN EPSILON(TM) IGE REAGENT KIT | Jun 16, 1989 |
| K872801 | Diagnostic Products | ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5 | Sep 10, 1987 |
| K860851 | Nichols Institute Diagnostics | ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM | Mar 28, 1986 |
| K853607 | Dexall Biomedical Labs | ALLERG-E IGE ENZYME IMMUNOASSAY KIT | Nov 7, 1985 |
| K831984 | Diagnostic Reagent Tech | POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE | Nov 21, 1983 |
| K831987 | Beckman Instruments | EPSILON IGE TEST KIT | Oct 14, 1983 |
| K831774 | Diagnostic Reagent Tech | LOGIPE A DATA REDUCSYSTEM IP SPECIFIC- | Jul 18, 1983 |
| K830653 | Diagnostic Reagent Tech | POLYSTYRENE MICROTITER PLATE IMMUNOSORB | Apr 8, 1983 |
| K830495 | Diagnostic Reagent Tech | POLYSTYRENE MICROTITER PLATE IMMUNOSOR | Apr 5, 1983 |
| K821094 | Diagnostic Reagent Tech | IP SPECIFIC E | May 7, 1982 |
| K800995 | Calbiochem-Behring | IMMUNOGLOBULIN E TEST KIT | May 14, 1980 |