FDA product code DKP: Radioimmunoassay, Phenobarbital
DKP is the FDA product code for radioimmunoassay, phenobarbital. It is a Class II device, regulated under 21 CFR 862.3660 and reviewed by the Clinical Toxicology panel. FDA has cleared 3 510(k) submissions under DKP, from 3 different applicants. The average 510(k) review took 21 days (median 21).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Phenobarbital |
| Device class | Class II |
| Regulation | 21 CFR 862.3660 |
| 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 DKP clearance
Top DKP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1984-11-27 |
| Bio-Rad | 1 | 1980-01-23 |
| Clinical Assays, Inc. | 1 | 1977-11-28 |
Most recent DKP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K844167 | Bd Becton Dickinson Vacutainer Systems Preanalytic | ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT | 1984-11-27 | 33 |
| K800090 | Bio-Rad | FLUOROMATIC PHENOLBARBITAL FIA | 1980-01-23 | 9 |
| K772111 | Clinical Assays, Inc. | IN VITRO PHENOBARBITAL RIA TEST | 1977-11-28 | 21 |
Recalls for DKP devices
openFDA lists no recalls for product code DKP.
Frequently asked questions
What is FDA product code DKP?
DKP is the FDA product code for radioimmunoassay, phenobarbital. It is a Class II device, regulated under 21 CFR 862.3660 and reviewed by the Clinical Toxicology panel.
What device class is DKP?
Class II, regulation 21 CFR 862.3660. Typical premarket route: 510(k).
How long does a 510(k) take for product code DKP?
Across 3 cleared submissions the average was 21 days from receipt to decision (median 21).
Which companies have the most DKP clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (1); Bio-Rad (1); Clinical Assays, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DKP
- Run a recall and safety report across every DKP manufacturer
- Watch product code DKP 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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