FDA product code DOG: Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol
DOG is the FDA product code for radioimmunoassay, digoxin (125-i), rabbit antibody, polyethylene glycol. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel. FDA has cleared 5 510(k) submissions under DOG, from 5 different applicants. The average 510(k) review took 21 days (median 21).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol |
| Device class | Class II |
| Regulation | 21 CFR 862.3320 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DOG clearance
Top DOG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Corp. of America | 1 | 1981-03-11 |
| American Dade | 1 | 1980-12-22 |
| Ortho Diagnostics, Inc. | 1 | 1978-08-31 |
| Syva Co. | 1 | 1976-10-21 |
| Dade, Baxter Travenol Diagnostics, Inc. | 1 | 1976-08-23 |
Most recent DOG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K810477 | Diagnostic Corp. of America | DCA DIGOX-SYN RIA TEST | 1981-03-11 | 16 |
| K803045 | American Dade | IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. | 1980-12-22 | 21 |
| K781335 | Ortho Diagnostics, Inc. | DIGOXIN RIA (PEG) KIT | 1978-08-31 | 29 |
| K760709 | Syva Co. | EMIT DIGOKIN ASSAY | 1976-10-21 | 27 |
| K760416 | Dade, Baxter Travenol Diagnostics, Inc. | DATA-TOPE SYSTEM DIGOXIN RIA | 1976-08-23 | 14 |
Recalls for DOG devices
openFDA lists no recalls for product code DOG.
Frequently asked questions
What is FDA product code DOG?
DOG is the FDA product code for radioimmunoassay, digoxin (125-i), rabbit antibody, polyethylene glycol. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel.
What device class is DOG?
Class II, regulation 21 CFR 862.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code DOG?
Across 5 cleared submissions the average was 21 days from receipt to decision (median 21).
Which companies have the most DOG clearances?
Diagnostic Corp. of America (1); American Dade (1); Ortho Diagnostics, Inc. (1); Syva Co. (1); Dade, Baxter Travenol Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DOG
- Run a recall and safety report across every DOG manufacturer
- Watch product code DOG 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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