FDA product code DOY: Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
DOY is the FDA product code for radioimmunoassay, digoxin (3-h), goat antibody, 2nd antibody sep.. 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 DOY, from 4 different applicants. The average 510(k) review took 44 days (median 40).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. |
| 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 DOY clearance
Top DOY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medrad, Inc. | 2 | 1983-05-09 |
| C.R. Bard, Inc. | 1 | 1991-04-09 |
| Gish Biomedical, Inc. | 1 | 1983-08-31 |
| Medical Parameters, Inc. | 1 | 1983-05-25 |
Most recent DOY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K910154 | C.R. Bard, Inc. | USCI ILLUMEN-8 8F PTCA GUIDING CATHETER | 1991-04-09 | 85 |
| K832396 | Gish Biomedical, Inc. | CENTRAL VENOUS ACCESS CATHETER CVAC | 1983-08-31 | 42 |
| K831239 | Medical Parameters, Inc. | WALRUS PERCUTANEOUS INTRODUCER SET | 1983-05-25 | 40 |
| K831188 | Medrad, Inc. | CONNECTOR TUBE | 1983-05-09 | 27 |
| K831191 | Medrad, Inc. | VASCULAR CATHETER | 1983-05-09 | 27 |
Recalls for DOY devices
openFDA lists no recalls for product code DOY.
Frequently asked questions
What is FDA product code DOY?
DOY is the FDA product code for radioimmunoassay, digoxin (3-h), goat antibody, 2nd antibody sep.. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel.
What device class is DOY?
Class II, regulation 21 CFR 862.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code DOY?
Across 5 cleared submissions the average was 44 days from receipt to decision (median 40).
Which companies have the most DOY clearances?
Medrad, Inc. (2); C.R. Bard, Inc. (1); Gish Biomedical, Inc. (1); Medical Parameters, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DOY
- Run a recall and safety report across every DOY manufacturer
- Watch product code DOY 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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