FDA Product Code
FDA Product Code DGO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5510
510(k) Clearances — 15 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K943194 | IMMULITE(R) ALLERGY FOOD PANEL FP5E | Diagnostic Products Corp. | 1995-02-23 | Traditional | PDF ↗ |
| K920087 | IGE EIA TEST KIT | The Binding Site, Ltd. | 1992-09-14 | Traditional | PDF ↗ |
| K911511 | ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED | Diagnostic Products Corp. | 1991-04-17 | Traditional | PDF ↗ |
| K894039 | QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION | Quidel Corp. | 1989-07-14 | Traditional | PDF ↗ |
| K893125 | BECKMAN EPSILON(TM) IGE REAGENT KIT | Beckman Instruments, Inc. | 1989-06-16 | Traditional | PDF ↗ |
| K872801 | ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5 | Diagnostic Products Corp. | 1987-09-10 | Traditional | PDF ↗ |
| K860851 | ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM | Nichols Institute Diagnostics | 1986-03-28 | Traditional | PDF ↗ |
| K853607 | ALLERG-E IGE ENZYME IMMUNOASSAY KIT | Dexall Biomedical Labs, Inc. | 1985-11-07 | Traditional | PDF ↗ |
| K831984 | POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE | Diagnostic Reagent Tech. | 1983-11-21 | Traditional | PDF ↗ |
| K831987 | EPSILON IGE TEST KIT | Beckman Instruments, Inc. | 1983-10-14 | Traditional | PDF ↗ |
| K831774 | LOGIPE A DATA REDUCSYSTEM IP SPECIFIC- | Diagnostic Reagent Tech. | 1983-07-18 | Traditional | PDF ↗ |
| K830653 | POLYSTYRENE MICROTITER PLATE IMMUNOSORB | Diagnostic Reagent Tech. | 1983-04-08 | Traditional | PDF ↗ |
| K830495 | POLYSTYRENE MICROTITER PLATE IMMUNOSOR | Diagnostic Reagent Tech. | 1983-04-05 | Traditional | PDF ↗ |
| K821094 | IP SPECIFIC E | Diagnostic Reagent Tech. | 1982-05-07 | Traditional | PDF ↗ |
| K800995 | IMMUNOGLOBULIN E TEST KIT | Calbiochem-Behring Corp. | 1980-05-14 | Traditional | PDF ↗ |
Product code DGO · Class II · Immunology. Data: openFDA.