FDA product code DLP: Radioimmunoassay, Diphenylhydantoin
DLP is the FDA product code for radioimmunoassay, diphenylhydantoin. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel. FDA has cleared 5 510(k) submissions under DLP, from 5 different applicants. The average 510(k) review took 34 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Diphenylhydantoin |
| Device class | Class II |
| Regulation | 21 CFR 862.3350 |
| 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 DLP clearance
Top DLP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Colony Laboratories, Inc. | 1 | 1989-09-25 |
| Kallestad Laboratories, Inc. | 1 | 1981-07-10 |
| Bio-Rad | 1 | 1980-01-11 |
| Ventrex Laboratories, Inc. | 1 | 1979-10-17 |
| Amersham Corp. | 1 | 1977-06-17 |
Most recent DLP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K894527 | Colony Laboratories, Inc. | FPR PHENYTOIN KIT | 1989-09-25 | 67 |
| K811775 | Kallestad Laboratories, Inc. | KALLESTAD ANTISERA TO PHENYTOIN | 1981-07-10 | 17 |
| K792640 | Bio-Rad | FLUOROMATIC PHENYTOIN FIA | 1980-01-11 | 15 |
| K791896 | Ventrex Laboratories, Inc. | CENTRIA PHENYTOIN RIA TEST SET | 1979-10-17 | 22 |
| K770779 | Amersham Corp. | PHENYTOIN RIA KIT | 1977-06-17 | 49 |
Recalls for DLP devices
openFDA lists no recalls for product code DLP.
Frequently asked questions
What is FDA product code DLP?
DLP is the FDA product code for radioimmunoassay, diphenylhydantoin. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel.
What device class is DLP?
Class II, regulation 21 CFR 862.3350. Typical premarket route: 510(k).
How long does a 510(k) take for product code DLP?
Across 5 cleared submissions the average was 34 days from receipt to decision (median 22).
Which companies have the most DLP clearances?
Colony Laboratories, Inc. (1); Kallestad Laboratories, Inc. (1); Bio-Rad (1); Ventrex Laboratories, Inc. (1); Amersham Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DLP
- Run a recall and safety report across every DLP manufacturer
- Watch product code DLP 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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