FDA product code DGO: Ige, Peroxidase, Antigen, Antiserum, Control
DGO is the FDA product code for ige, peroxidase, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Pathology panel. FDA has cleared 15 510(k) submissions under DGO, from 8 different applicants. The average 510(k) review took 78 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Ige, Peroxidase, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| Review panel | PA — Pathology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DGO clearance
Top DGO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Reagent Tech. | 5 | 1983-11-21 |
| Diagnostic Products Corp. | 3 | 1995-02-23 |
| Beckman Instruments, Inc. | 2 | 1989-06-16 |
| The Binding Site, Ltd. | 1 | 1992-09-14 |
| Quidel Corp. | 1 | 1989-07-14 |
3 more applicants have DGO clearances. See the full list in Caduvo.
Most recent DGO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K943194 | Diagnostic Products Corp. | IMMULITE(R) ALLERGY FOOD PANEL FP5E | 1995-02-23 | 233 |
| K920087 | The Binding Site, Ltd. | IGE EIA TEST KIT | 1992-09-14 | 250 |
| K911511 | Diagnostic Products Corp. | ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED | 1991-04-17 | 13 |
| K894039 | Quidel Corp. | QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION | 1989-07-14 | 38 |
| K893125 | Beckman Instruments, Inc. | BECKMAN EPSILON(TM) IGE REAGENT KIT | 1989-06-16 | 52 |
Recalls for DGO devices
openFDA lists no recalls for product code DGO.
Frequently asked questions
What is FDA product code DGO?
DGO is the FDA product code for ige, peroxidase, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Pathology panel.
What device class is DGO?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code DGO?
Across 15 cleared submissions the average was 78 days from receipt to decision (median 48).
Which companies have the most DGO clearances?
Diagnostic Reagent Tech. (5); Diagnostic Products Corp. (3); Beckman Instruments, Inc. (2); The Binding Site, Ltd. (1); Quidel Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DGO
- Run a recall and safety report across every DGO manufacturer
- Watch product code DGO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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