FDA product code DOK: Free Radical Assay, Morphine
DOK is the FDA product code for free radical assay, morphine. It is a Class II device, regulated under 21 CFR 862.3640 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DOK. The average 510(k) review took 64 days (median 64).
Classification
| Field | Value |
|---|---|
| Device name | Free Radical Assay, 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 DOK clearance
Top DOK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1981-08-13 |
Most recent DOK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K811637 | Bd Becton Dickinson Vacutainer Systems Preanalytic | RUBELLA LATEX CARD TEST | 1981-08-13 | 64 |
Recalls for DOK devices
openFDA lists no recalls for product code DOK.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J2274 — Injection, morphine sulfate, preservative-free for epidural or intrathecal use, 10 mg
Frequently asked questions
What is FDA product code DOK?
DOK is the FDA product code for free radical assay, morphine. It is a Class II device, regulated under 21 CFR 862.3640 and reviewed by the Clinical Toxicology panel.
What device class is DOK?
Class II, regulation 21 CFR 862.3640. Typical premarket route: 510(k).
How long does a 510(k) take for product code DOK?
Across 1 cleared submissions the average was 64 days from receipt to decision (median 64).
Which companies have the most DOK clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DOK
- Run a recall and safety report across every DOK manufacturer
- Watch product code DOK 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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