FDA product code DOA: Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.
DOA is the FDA product code for radioimmunoassay, digoxin (125-i), goat antibody, anion exchange, resin sep.. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DOA. The average 510(k) review took 397 days (median 397). FDA has posted 1 recall for DOA devices.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin 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 DOA clearance
Top DOA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Linde Medical Sensors AG | 1 | 2004-08-24 |
Most recent DOA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K032291 | Linde Medical Sensors AG | TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM | 2004-08-24 | 397 |
Recalls for DOA devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-10-15.
Frequently asked questions
What is FDA product code DOA?
DOA is the FDA product code for radioimmunoassay, digoxin (125-i), goat antibody, anion exchange, resin sep.. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel.
What device class is DOA?
Class II, regulation 21 CFR 862.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code DOA?
Across 1 cleared submissions the average was 397 days from receipt to decision (median 397).
Which companies have the most DOA clearances?
Linde Medical Sensors AG (1).
Have DOA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2007-10-15.
Next steps
- Run an FDA pathway report with predicate devices for product code DOA
- Run a recall and safety report across every DOA manufacturer
- Watch product code DOA 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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