FDA product code CZK: Iga, Rhodamine, Antigen, Antiserum, Control
CZK is the FDA product code for iga, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under CZK. The average 510(k) review took 58 days (median 58).
Classification
| Field | Value |
|---|---|
| Device name | Iga, Rhodamine, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| 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 CZK clearance
Top CZK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Instrumentation Laboratory CO | 1 | 1984-01-04 |
Most recent CZK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833841 | Instrumentation Laboratory CO | IL TEST IGG IGA & IGM KITS | 1984-01-04 | 58 |
Recalls for CZK devices
openFDA lists no recalls for product code CZK.
Frequently asked questions
What is FDA product code CZK?
CZK is the FDA product code for iga, rhodamine, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is CZK?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code CZK?
Across 1 cleared submissions the average was 58 days from receipt to decision (median 58).
Which companies have the most CZK clearances?
Instrumentation Laboratory CO (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CZK
- Run a recall and safety report across every CZK manufacturer
- Watch product code CZK 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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