FDA product code DIJ: Lead, Delta Amino Levulinic Acid
DIJ is the FDA product code for lead, delta amino levulinic acid. It is a Class II device, regulated under 21 CFR 862.3550 and reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under DIJ, from 2 different applicants. The average 510(k) review took 36 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Lead, Delta Amino Levulinic Acid |
| Device class | Class II |
| Regulation | 21 CFR 862.3550 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every DIJ clearance
Top DIJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quantimetrix Corp. | 1 | 2003-04-03 |
| Volu Sol Medical Industries | 1 | 1980-01-16 |
Most recent DIJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K030826 | Quantimetrix Corp. | PRECISET DAT AMPHETAMINE | 2003-04-03 | 20 |
| K792407 | Volu Sol Medical Industries | ELVI-AMINOLEVULINIC ACID | 1980-01-16 | 51 |
Recalls for DIJ devices
openFDA lists no recalls for product code DIJ.
Frequently asked questions
What is FDA product code DIJ?
DIJ is the FDA product code for lead, delta amino levulinic acid. It is a Class II device, regulated under 21 CFR 862.3550 and reviewed by the Clinical Toxicology panel.
What device class is DIJ?
Class II, regulation 21 CFR 862.3550. Typical premarket route: 510(k).
How long does a 510(k) take for product code DIJ?
Across 2 cleared submissions the average was 36 days from receipt to decision (median 36).
Which companies have the most DIJ clearances?
Quantimetrix Corp. (1); Volu Sol Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DIJ
- Run a recall and safety report across every DIJ manufacturer
- Watch product code DIJ 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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