FDA product code CJQ: Radial Immunodiffusion, Albumin
CJQ is the FDA product code for radial immunodiffusion, albumin. It is a Class II device, regulated under 21 CFR 862.1035 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under CJQ. The average 510(k) review took 17 days (median 17).
Classification
| Field | Value |
|---|---|
| Device name | Radial Immunodiffusion, Albumin |
| Device class | Class II |
| Regulation | 21 CFR 862.1035 |
| 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 CJQ clearance
Top CJQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meloy Laboratories, Inc. | 1 | 1981-05-15 |
Most recent CJQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K811178 | Meloy Laboratories, Inc. | HUMAN IGG-ALBUMIN TEST KIT | 1981-05-15 | 17 |
Recalls for CJQ devices
openFDA lists no recalls for product code CJQ.
Frequently asked questions
What is FDA product code CJQ?
CJQ is the FDA product code for radial immunodiffusion, albumin. It is a Class II device, regulated under 21 CFR 862.1035 and reviewed by the Clinical Chemistry panel.
What device class is CJQ?
Class II, regulation 21 CFR 862.1035. Typical premarket route: 510(k).
How long does a 510(k) take for product code CJQ?
Across 1 cleared submissions the average was 17 days from receipt to decision (median 17).
Which companies have the most CJQ clearances?
Meloy Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CJQ
- Run a recall and safety report across every CJQ manufacturer
- Watch product code CJQ 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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