FDA product code DJJ: Fluorometry, Morphine
DJJ is the FDA product code for fluorometry, 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 DJJ. The average 510(k) review took 49 days (median 49).
Classification
| Field | Value |
|---|---|
| Device name | Fluorometry, 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 DJJ clearance
Top DJJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Branan Medical Corp. | 1 | 2001-11-07 |
Most recent DJJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K013124 | Branan Medical Corp. | MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP | 2001-11-07 | 49 |
Recalls for DJJ devices
openFDA lists no recalls for product code DJJ.
Frequently asked questions
What is FDA product code DJJ?
DJJ is the FDA product code for fluorometry, morphine. It is a Class II device, regulated under 21 CFR 862.3640 and reviewed by the Clinical Toxicology panel.
What device class is DJJ?
Class II, regulation 21 CFR 862.3640. Typical premarket route: 510(k).
How long does a 510(k) take for product code DJJ?
Across 1 cleared submissions the average was 49 days from receipt to decision (median 49).
Which companies have the most DJJ clearances?
Branan Medical Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DJJ
- Run a recall and safety report across every DJJ manufacturer
- Watch product code DJJ 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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