FDA product code CZM: Iga, Ferritin, Antigen, Antiserum, Control
CZM is the FDA product code for iga, ferritin, 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 CZM. The average 510(k) review took 15 days (median 15).
Classification
| Field | Value |
|---|---|
| Device name | Iga, Ferritin, 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 CZM clearance
Top CZM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boehringer Mannheim Corp. | 1 | 1987-03-24 |
Most recent CZM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K870930 | Boehringer Mannheim Corp. | TINA-QUANT(R) (A) C3 | 1987-03-24 | 15 |
Recalls for CZM devices
openFDA lists no recalls for product code CZM.
Frequently asked questions
What is FDA product code CZM?
CZM is the FDA product code for iga, ferritin, 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 CZM?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code CZM?
Across 1 cleared submissions the average was 15 days from receipt to decision (median 15).
Which companies have the most CZM clearances?
Boehringer Mannheim Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CZM
- Run a recall and safety report across every CZM manufacturer
- Watch product code CZM 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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