FDA product code DPK: Liquid Chromatography, Morphine
DPK is the FDA product code for liquid chromatography, morphine. It is a Class II device, regulated under 21 CFR 862.3640 and reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under DPK. The average 510(k) review took 192 days (median 192).
Classification
| Field | Value |
|---|---|
| Device name | Liquid Chromatography, Morphine |
| Device class | Class II |
| Regulation | 21 CFR 862.3640 |
| 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 DPK clearance
Top DPK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alfa Scientific Designs, Inc. | 2 | 2000-07-10 |
Most recent DPK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K994409 | Alfa Scientific Designs, Inc. | INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST | 2000-07-10 | 195 |
| K994404 | Alfa Scientific Designs, Inc. | INSTANT-VIEW MORPHINE URINE CASSETTE TEST | 2000-07-05 | 190 |
Recalls for DPK devices
openFDA lists no recalls for product code DPK.
Frequently asked questions
What is FDA product code DPK?
DPK is the FDA product code for liquid chromatography, morphine. It is a Class II device, regulated under 21 CFR 862.3640 and reviewed by the Clinical Toxicology panel.
What device class is DPK?
Class II, regulation 21 CFR 862.3640. Typical premarket route: 510(k).
How long does a 510(k) take for product code DPK?
Across 2 cleared submissions the average was 192 days from receipt to decision (median 192).
Which companies have the most DPK clearances?
Alfa Scientific Designs, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code DPK
- Run a recall and safety report across every DPK manufacturer
- Watch product code DPK 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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