FDA product code CZQ: Bence-Jones Protein, Antigen, Antiserum, Control
CZQ is the FDA product code for bence-jones protein, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5150 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under CZQ. The average 510(k) review took 24 days (median 24).
Classification
| Field | Value |
|---|---|
| Device name | Bence-Jones Protein, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5150 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CZQ clearance
Top CZQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kallestad Laboratories, Inc. | 2 | 1981-09-01 |
Most recent CZQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K812327 | Kallestad Laboratories, Inc. | KAPPA & LAMBDA BENCE JONES CONTROLS | 1981-09-01 | 14 |
| K802284 | Kallestad Laboratories, Inc. | ANTISERA TO HUMAN FREE LAMBDA LIGHT CH. | 1980-10-23 | 34 |
Recalls for CZQ devices
openFDA lists no recalls for product code CZQ.
Frequently asked questions
What is FDA product code CZQ?
CZQ is the FDA product code for bence-jones protein, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5150 and reviewed by the Immunology panel.
What device class is CZQ?
Class II, regulation 21 CFR 866.5150. Typical premarket route: 510(k).
How long does a 510(k) take for product code CZQ?
Across 2 cleared submissions the average was 24 days from receipt to decision (median 24).
Which companies have the most CZQ clearances?
Kallestad Laboratories, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code CZQ
- Run a recall and safety report across every CZQ manufacturer
- Watch product code CZQ 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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