FDA product code DKN: Radioimmunoassay, Barbiturate
DKN is the FDA product code for radioimmunoassay, barbiturate. It is a Class II device, regulated under 21 CFR 862.3150 and reviewed by the Clinical Toxicology panel. FDA has cleared 4 510(k) submissions under DKN, from 2 different applicants. The average 510(k) review took 51 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Barbiturate |
| Device class | Class II |
| Regulation | 21 CFR 862.3150 |
| 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 DKN clearance
Top DKN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostic Systems, Inc. | 2 | 1991-10-30 |
| Hoffmann-La Roche, Inc. | 2 | 1983-03-10 |
Most recent DKN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K914468 | Roche Diagnostic Systems, Inc. | ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES | 1991-10-30 | 23 |
| K881816 | Roche Diagnostic Systems, Inc. | ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES | 1988-07-28 | 91 |
| K830479 | Hoffmann-La Roche, Inc. | ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE | 1983-03-10 | 23 |
| K812988 | Hoffmann-La Roche, Inc. | AGGLUTEX BARBITURATES TEST KIT | 1981-12-31 | 66 |
Recalls for DKN devices
openFDA lists no recalls for product code DKN.
Frequently asked questions
What is FDA product code DKN?
DKN is the FDA product code for radioimmunoassay, barbiturate. It is a Class II device, regulated under 21 CFR 862.3150 and reviewed by the Clinical Toxicology panel.
What device class is DKN?
Class II, regulation 21 CFR 862.3150. Typical premarket route: 510(k).
How long does a 510(k) take for product code DKN?
Across 4 cleared submissions the average was 51 days from receipt to decision (median 44).
Which companies have the most DKN clearances?
Roche Diagnostic Systems, Inc. (2); Hoffmann-La Roche, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code DKN
- Run a recall and safety report across every DKN manufacturer
- Watch product code DKN 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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