FDA product code JLJ: Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate
JLJ is the FDA product code for uridine-5-diphosphoglucose, nad (u.v.), alpha-d galactose-1-phosphate. It is a Class II device, regulated under 21 CFR 862.1315 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JLJ. The average 510(k) review took 55 days (median 55). FDA has posted 1 recall for JLJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate |
| Device class | Class II |
| Regulation | 21 CFR 862.1315 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JLJ clearance
Top JLJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Specialties, Inc. | 1 | 1986-04-07 |
Most recent JLJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K860501 | Medical Specialties, Inc. | FLAME PHOTOMETER STANDARD | 1986-04-07 | 55 |
Recalls for JLJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-06-27.
Frequently asked questions
What is FDA product code JLJ?
JLJ is the FDA product code for uridine-5-diphosphoglucose, nad (u.v.), alpha-d galactose-1-phosphate. It is a Class II device, regulated under 21 CFR 862.1315 and reviewed by the Clinical Chemistry panel.
What device class is JLJ?
Class II, regulation 21 CFR 862.1315. Typical premarket route: 510(k).
How long does a 510(k) take for product code JLJ?
Across 1 cleared submissions the average was 55 days from receipt to decision (median 55).
Which companies have the most JLJ clearances?
Medical Specialties, Inc. (1).
Have JLJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2003-06-27.
Next steps
- Run an FDA pathway report with predicate devices for product code JLJ
- Run a recall and safety report across every JLJ manufacturer
- Watch product code JLJ 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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