FDA product code CZY: Complement C1s, Antigen, Antiserum, Control
CZY is the FDA product code for complement c1s, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5240 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under CZY. The average 510(k) review took 30 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Complement C1s, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5240 |
| 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 CZY clearance
Top CZY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cytotech, Inc. | 1 | 1987-11-25 |
Most recent CZY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K874379 | Cytotech, Inc. | CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY | 1987-11-25 | 30 |
Recalls for CZY devices
openFDA lists no recalls for product code CZY.
Frequently asked questions
What is FDA product code CZY?
CZY is the FDA product code for complement c1s, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5240 and reviewed by the Immunology panel.
What device class is CZY?
Class II, regulation 21 CFR 866.5240. Typical premarket route: 510(k).
How long does a 510(k) take for product code CZY?
Across 1 cleared submissions the average was 30 days from receipt to decision (median 30).
Which companies have the most CZY clearances?
Cytotech, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CZY
- Run a recall and safety report across every CZY manufacturer
- Watch product code CZY 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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