FDA product code DJA: Column Supports, Glc
DJA is the FDA product code for column supports, glc. It is a Class I device, regulated under 21 CFR 862.2250 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DJA. The average 510(k) review took 26 days (median 26).
Classification
| Field | Value |
|---|---|
| Device name | Column Supports, Glc |
| Device class | Class I |
| Regulation | 21 CFR 862.2250 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DJA clearance
Top DJA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Supelco, Inc. | 1 | 1980-08-27 |
Most recent DJA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K801833 | Supelco, Inc. | GAS-CHROMATOGRAPHIC PACKING | 1980-08-27 | 26 |
Recalls for DJA devices
openFDA lists no recalls for product code DJA.
Frequently asked questions
What is FDA product code DJA?
DJA is the FDA product code for column supports, glc. It is a Class I device, regulated under 21 CFR 862.2250 and reviewed by the Clinical Toxicology panel.
What device class is DJA?
Class I, regulation 21 CFR 862.2250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DJA?
Across 1 cleared submissions the average was 26 days from receipt to decision (median 26).
Which companies have the most DJA clearances?
Supelco, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DJA
- Run a recall and safety report across every DJA manufacturer
- Watch product code DJA 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.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times